herniann 7 - 3b

Technische Dokumentation
Rev 01
EG- Konformitätserklärung
Declaration of Conformity
Das Unternehmen / The Company
Hermann Medizintechnik GmbH
Württemberger Straße 26
D-78567 Fridingen
erklärt hiermit unter alleiniger Verantwortung, dass folgende Produkte, siehe Anhang I
herewith declares under sole responsibility, that following products, according Annex I
Chirurgische Instrumente
Klasse I siehe beigefügte Anhangsliste.
den grundlegenden Anforderungen folgender Richtlinie entsprechen:
are in compliance with the following directi'le:
EG-Richtlinie für Medizinprodukte 93/42/EWG
European Medical Device Directive 93/42/EEC
Der Hersteller hat die Technische Dokumentation zusammengestellt.
The manufacturer has compiled the technical documentation.
Die gelisteten Produkte sind konform mit den Grundlegenden Anforderungen des Anhang
I der EG-Richtlinie 93/42/EWG und werden somit mit (
Verkehr gebracht.
€ gekennzeichnet,
von uns in
The listed products are conform to the essential requirements of the Medical Device
Directive 93/42/EEC Annex I and are therefore placed into market with
(€.
Diese Erklärung besitzt eine Gültigkeit bis einschließlich 08,11.2018
This dec!aration is valid until2018-11-08
HERNIANN
7
MfDIZINTE(HI~IK
Hermann Medizintechnik GmbH
Datum / Date: 12.01.2015
Würffemberger
D -78567
ToI.07463/9967.0.
Alig _Kll Ol-lS.doc
Straße 2
Fridingen/Tu""
..
..
Fox9~~~~aftSfuhrung D niela Hermann
Seite 1 von 13
Technische
Dokumentation
Rev 01
Anhang I Produktliste zur Konformitätserklärung
Annex I Product list Declaration of Conformity
Artikelnummer
Artiele Number
Artikelbezeichnung
Description
Klasse
e/ass
Regel
Ru/e
12-986
I
1
17-929
I
1
Slethoscope
13-750
I
1
Head Light
11-963
I
12
$102-0240
Head Mirror
11-960
I
1
$102-0260
Ophtalmoscope
12-815
I
1
$102-0300
Otoscope sets
12-849
I
5
$102-0340
Vena tourniquet
14-072
I
1
$104-0020
Katheter forceps
11-774
I
6
$104-0040
Laryngoscope(baUery)
15-076
I
12
$104-0060
Laryngoscope, Accessory
15-076
I
6
$106-0020
Amputation knife
12-239
I
6
$106-0060
Dermatome
11-179
I
6
$106-0065
Dermatome Einmalprodukte
11-179
I
6
$106-0080
Brain knife
12-239
I
6
$106-0100
Carlilage knife
12-239
I
6
$106-0140
Operationscalpel
12.252
I
6
$106-0145
Operalionsscalpel
12,252
I
6
$106-0180
Blade holder I brakers
12-236
I
6
$106-0200
Shavin knives
12-239
I
6
$106-0220
Resection knives
12-239
I
6
$106-0260
Scalpes
12-252
I
6
$108-0040
Surg. Gum scissors
13-480
I
6
$108-0060
Enterotomy scissors
13-480
I
6
$108-0080
Episiotomy scissors
13-480
I
6
$108-0100
Suture scissors
13-480
I
6
$108-0140
Vascular scissors
13-480
I
6
$108-0160
Gynaecological
13-493
I
6
$108-0180
Stitch scissors
13-480
I
6
$108-0220
Umbilical scissors
13-480
I
6
$108-0260
Dissection scissors
13-492
I
6
$108-0280
Scissors for neurosurgery
13-496
I
6
$108-0320
Thorax scissors
13-504
I
6
$108-0340
Tonsil & nasal scissors
13-480
I
6
$108.0360
Plastiic scissors
13-500
I
6
$108-0400
Bandage scissors
13-481
I
6
$102-0060
Percussion hammers
$102-0140
Goniometer (not calibrated)
$102-0180
$102-0200
Alig _Kll Ol-lS.doc
single use
scissors
UMDNS Code
Seite 2 von 13
Technische
Artikelnummer
ArticJe Number
Dokumentation
Artikelbezeichnung
Description
UMDNS Code
Rev 01
Klasse
Class
Regel
Rute
$108-0420
Wire seissors
13-041
I
6
$108-0440
Left handed seissors
13-480
I
6
$109-0020
Eye seissors
15-246
I
6
$109-0040
Miero seissors
13-480
I
6
$110-0020
Anatomie foreeps
15-800
I
6
$110-0040
Surgieal foreeps
15-800
[
6
$110-0120
Skin foreeps
14-257
I
6
$110-0160
Forceps, TC
14-257
I
6
$110-0200
Splinter foreeps
14-257
[
6
$111-0020
M'erosurgery foreeps
14-257
I
6
$111-0040
Atrauma-foreeps
14-257
I
6
$112-0040
Artery I bronchus fore pes
10-867
I
6
$112-0080
Bulldog foreeps
10-868
I
6
$112-0100
Pressure foreeps
10-861
I
6
$112-0120
Gall ductus foreeps
10-861
I
6
$112-0160
Hystereetomy foreeps
10-861
I
6
$112-0240
Kidney pedieal elamps
16-519
I
6
$112-0260
Peritoneum foreeps
10-861
I
6
$112-0280
Disseeting I Ligature foreeps
10-861
I
6
$112-0300
Tubing Clamps
10-875
I
6
$112-0320
Atrauma elamps
10-861
I
6
$114-0020
Towel forcpes
10-861
I
6
$116-0040
Dressing and Polypus foreeps
11-774
I
6
Polypus-, Tumor-, Sponge
foreeps
11-774
I
$116-0100
$118-0080
Spades
13-645
I
6
$118-0100
Retraetors (hand worked)
13-373
I
6
$120-0020
Varieosity set
15-895
I
6
$120-0040
Ri1g stripper
13-823
I
6
$120-0080
Sondes
15-237
I
6
$120-0100
Cotton applieatos
10-172
[
6
$122-0020
Biopsyeanulas
10-561
I
6
$122-0040
Guiding needles
15-868
I
6
$122-0120
Troears
14-154
I
6
$124-0020
Miero needle holder
12-726
I
6
$124-0040
Needle holder
12-726
I
6
$124-0060
Needle holder, TC
12-726
I
6
$126-0020
S~rgieal needles (non sterile)
12-729
I
6
$126-0060
Ligature eondueturs
13-117
I
6
Allg _K11 01-15.doc
6
Seite 3 von 13
Technische Dokumentation
Artikelnummer
Artiele Number
Artikelbezeichnung
Description
UMDNS Code
Rev 01
Klasse
Cfass
Regel
Rufe
$126-0160
Reverdin-needles
12-729
I
6
$126-0180
Ligatur needles
12-729
I
6
$126-0220
Clips and Instruments
10-894
I
6
$128-0020
Forceps f. Syringes + Canulas
14-257
I
1
$128-0040
Sterilization forceps
11-792
I
1
$128-0060
Sterilization clamps
16-771
I
1
$130-0020
Piaster forceps
11-774
I
1
$130-0040
Piaster knives
12-251
I
1
$130-0060
Piaster scissors
13-480
I
1
$130-0080
Piaster spreader
13-707
I
1
$130-0100
Piaster cast euter (meeh.)
10-655
I
1
$130-0120
Cloth and piaster scissors
13-480
I
1
$130-0140
Oszil!. Piaster scissors (electr.)
16-340
I
1
$130-0180
Saw blades
13-447
(
1
$132-0020
Draught instruments
13-827
I
6
$132-0040
Elevators
11-504
I
6
$132-0080
Bane rongeurs
13-416
I
6
$132-0100
Hammers
12-421
I
6
$132-0160
Bane Files
11-702
I
6
$132-0180
Bane holding clamps
11-774
I
6
$132-0200
Bane Levers
11-504
I
6
$132-0220
Bane chiseis
10-825
I
6
$132-0240
Bane splinter forceps
15-670
I
6
$132-0260
Chiseis and Osthotomes
10-825
I
6
$132-0280
Meniscotomes
12-248
I
6
$132-0300
Raspatories
11-504
I
6
$132-0360
Bane curettes
13-508
I
6
Tendon strippers
13-827
(
6
$132-0420
Autosy sets
15-895
(
6
$132-0440
Band-Spanner
13-827
I
6
$132-0460
Lead hands
13-357
I
6
$132-0480
Rachiotomes
10-825
I
6
$132-0500
Tendon holding foreps
11-797
I
6
$133-0010
Retractors
13-373
I
6
$133-0020
Amputation resection saws
13-448
I
6
$133-0030
Finger ring saws
13-448
I
1
$133-0050
Wire drill holder
11-930
I
6
$133-0100
Wire knippers
13-041
I
6
$133-0120
Wire knippers, TC
13-041
I
6
$132-0400
AligJll
Ol-15.doc
Seite 4 von 13
._
•.••
w
~.
Technische
Artikelnummer
Artiele Number
~
_
•••
_
••
Dokumentation
Artikelbezeichnung
Description
UMDNS Code
Rev 01
Klasse
Cfass
Regel
Rufe
$133-0160
Wire spanning instruments
14-455
I
6
$133-0200
Extension Bows
14-105
I
6
$133-0220
Graspin9 forceps
11-774
I
6
$133-0240
Flat now pliers
11-774
I
6
$133-0280
Bone hand drill
17-761
I
6
$133-0340
Awls
17-760
I
6
$133-0380
Screwdrivers
13-517
I
6
$133-0520
Bone Instruments
12-845
I
6
$133-0540
Screw holding forceps
11-774
I
6
$140-0020
Applying force ps
10-894
I
6
$140-0060
Laminectomy punches
13-228
I
6
$140-0100
Dura-Dissectors
16-879
I
6
$140-0200
Pituitary Forceps
14-257
I
6
$140-0220
Instruments f. cervical opening
14-064
I
6
$140-0240
Laminektomy rongeurs
15-669
I
6
$140-0260
Knives
12-239
I
6
$140-0380
Vertebra speaders
13-707
I
6
$140-0400
Wire saws
13-449
I
6
$140-0500
Cervical traction tongs
14-064
I
6
$140-0520
Chordotome
12-029
I
6
$142-0020
Locking elevators
11-504
I
6
$142-0040
Knives
12-239
I
6
$142-0060
Lid plates
13-049
I
6
$142-0080
Foreign body instruments
11-291
I
6
$142-0100
Cornea I scarifiers I dissectors.
16-879
I
6
$142-0120
Eye magnet
15-269
I
1
$142-0140
Cataract a foreign body needles
12-744
I
6
$142-0180
Fixiation forks
16-466
I
6
$142-0200
Chiseis
10-824
I
6
$142-0220
Hooks
12-028
I
6
$142-0240
Cystotomes
12-239
I
6
$142-0260
Spoons
13-508
I
6
$142-0280
Wire loops
13-621
I
6
$142-0300
Cyclodialysis spatulae
13-648
I
6
$142-0320
Marking instruments
12-440
I
6
$142-0340
Dilatators
11-254
I
6
$142-0360
Probes
13-119
I
6
$142-0400
Cauters
12-744
I
6
$142-0420
Forceps
14-257
I
6
Alig Jll 01-15.doc
Seite 5 von 13
Technische Dokumentation
Artikelnummer
Art/eie Number
Artikelbezeichnung
Descr/pt/on
Rev 01
Klasse
Cfass
Regel
Rufe
13-381
I
6
UMDNS Code
$142-0440
B'epharostat-Lid
$143-0400
Foreeps
14-257
I
6
$143-0420
Trephines
14-146
I
6
$143-0440
Tonometers
16-809
I
5
$143-0460
Eye eanulas
10-573
I
5
$144-0060
Hammer head foreeps
11-774
I
6
$144-0100
Curettes
11-084
I
6
$144-0180
Miero ear seissors
13-480
I
6
$144-0200
Miero ear foeeps
11-774
I
6
Needles IHooks w. angled
shaft.
13-996
I
$144-0220
$144-0240
Needles/Hooks w. straight shaft
13-996
I
6
$144-0280
Ear foreeps
14-257
I
6
$144-0300
Ear speeulae
15-602
I
6
$144-0320
Ear syrringes
13-929
I
6
$144-0340
Paraeentesis needles
12-729
I
6
$144-0360
Polype snares
13-631
I
6
$144-0400
Tuning forks
14-255
I
1
$144-0420
Foreign body levers
11-506
I
1
$144-0440
Catheters
10-685
I
6
$144-0460
Noise apparatus
14-255
I
1
$144-0480
Air bag
11-376
I
1
$144-0500
Ear foreeps
11-774
I
6
$144-0520
Ear knives
12-245
I
6
$144-0540
Earspoons
13-508
I
6
$144-0560
Ear hookles
13-996
I
6
$144-0580
Ear needles
12-729
I
6
$144-0600
Powder blowers
11-585
I
1
$144-0620
Snares
13-621
I
6
$144-0640
Elevators
11-506
I
6
$144-0660
Chiseis
10-824
I
6
$146-0220
Gore bone punehes
13-228
I
6
$146-0260
Maxillary sinus punees
13-996
I
6
$146-0380
Nose ehisel instruments
10-828
I
6
$146-0400
Nose plastie & operation knives
12-239
I
6
$146-0440
Nose speeulas
13-664
I
5
$146-0460
Curettes
11-084
I
6
$146-0540
Ring knives
12-239
I
6
$146-0550
Nose punehes
11-774
I
6
AligJll
Ol-15.doc
holder
6
Seite 6 von 13
Technische
~W'_~~U
Artikelnummer
Artiele Number
Dokumentation
__
,_'
Rev 01
•
Artikelbezeichnung
Description
UMDNS Code
Klasse
e/ass
Regel
Ru/e
$146-0560
Stlarp nose punches
11-774
I
6
$146-0600
Sept. -/Periost -Elevators
11-504
I
6
$146-0620
Sept.Elev.-lnstr.
11-506
I
6
$146-0760
Septum punches
11-774
I
6
$146-0800
Tonsillotomes
14-070
I
6
$146-0840
Nose mirrors
12-547
I
6
$146-0850
Nose forceps
14-257
I
6
$146-0860
Polypus snares
13-631
I
6
$146-0880
Snares
13-621
I
6
$146-0900
Knives
12-239
I
6
$146-0920
Rasps
13-290
I
6
$146-0940
Nose saw
17-858
[
6
$146-0960
Spoon
13-508
[
6
$148-0040
Mouth gag
11-822
[
5
$148-0060
Mouth gore, wood
11-822
[
5
$148-0080
Mouth gore, rubber
11-822
[
5
$148-0120
Repositioning forceps
11-774
[
6
$148-0180
Tongue depressors
13-645
[
5
$148-0190
Mouth spatula, wood
13-645
[
5
$148-0200
Mouth forceps
11-774
I
6
$148-0220
Lip I Cheak retractors
11-822
I
6
$148-0240
Fingerprotection
11-720
I
5
$150-0020
Enucleator
11-587
I
6
$150-0080
Tampon forceps
14-257
[
6
$150-0100
Tonsil compressors
14-070
I
6
$150-0120
Tonsil knives
12-255
I
6
$150-0140
Tonsil needles
15-234
I
6
$150-0160
Tonsil snares
13-632
I
6
$150-0180
Tonsil forcepsi grasping forceps
15-672
I
6
$150-0200
Larynx mirrors
12-549
I
6
$150-0220
Tampon-grasping
11-774
I
6
$150-0230
Retractors
15-242
I
6
$150-0260
Snares
13-621
I
6
$150-0280
S\'rringes
13-929
I
6
$150-0300
Tonsillotome
14-070
I
6
$150-0320
Dissectors
11-290
I
6
$150-0340
Elevators
11-504
I
6
$152-0020
Larynx polyp forceps
11-774
I
6
$152-0100
Epiglotis retractor
12-028
I
6
Allg _Kll Ol-lS.doc
F. Noseplastic.
forceps
Seite 7 von 13
-
--
Technische
Artikelnummer
Art/eIe Number
.. --
,-
-
-- - - ..
-
Dokumentation
Artikelbezeiehnung
Descr/pt/on
UMDNS Code
Rev 01
Klasse
Class
Regel
Rule
$152-0120
Tampon-forceps
14-257
I
6
$152-0140
Larynx mirror
12-549
I
6
$152-0160
Forceps
11-774
I
6
$154-0020
Irtubation tube
14-096
I
6
$154-0100
Tracheal-dilatators
11-263
I
6
$154-0120
Tracheal-hooklets
13-996
I
6
$154-0140
Tracheal-punches
13-228
I
6
$154-0160
Tracheal-trocars
14-162
I
6
$154-0180
Hooklets
13-996
I
6
$154-0200
PJnches
13-228
I
6
$154-0220
Retractors
11-822
I
6
$154-0260
Dilatators
11-263
I
6
$154-0280
Goitre grasping forceps
11-774
I
6
$154-0300
Goitre probe
15-237
I
6
$154-0320
Muscle clamps
10-861
I
6
$156-1100
Bronchus c1amps
10-867
I
6
$156-1200
Lunge spatula
13-649
I
6
$156-1300
Rb shears
13-480
I
6
$156-1340
Anastomoses clamps
10-861
I
6
$156-1360
Lung grasping forceps
11-787
I
6
$156-1380
Thorax spreader
13-709
I
6
$162-0020
Gall stane spoon
13-509
I
6
$162-0040
Gall stone probe
15-237
I
6
$162-0060
Gall stone forcpes
11-774
I
6
$162-0080
Ureterus clamps
10-861
[
6
$162-0100
Kidney stone probe
16-519
[
6
$162-0120
Kidney stone probe
15-237
[
6
Dilatators
11-254
[
6
$164-0020
Anastomoses c1amps.
10-861
[
6
$164-0040
Intestines & Somach clamps
10-861
[
6
Intestine clamps
10-871
[
6
IntestinelTissue
11-774
[
6
16-264
[
$162-0140
$164-0060
$164-0080
forceps
$164-0100
Stomach/lntestine
apparatus
$164-0120
Clips
16-771
[
6
$166-0020
Bladder retractor
13-707
I
6
$166-0040
Bladder spatula
13-645
I
6
$166-0060
Dilatation bougies
11-254
I
6
$166-0080
Metall-Catheter
10-764
I
6
Alig _Kll 01-15.doc
suturing
6
Seite 8 von 13
Technische
Artikelnummer
Articte Number
Dokumentation
Artikelbezeichnung
Description
UMDNS Code
Rev 01
Klasse
Class
Regel
Rute
$166-0100
Penile clamps
16-452
I
6
$166-0110
Prostate grasping forceps
11-774
I
6
$166-0120
Proste hook
12-028
I
6
$166-0140
Secretion spoon
13-508
I
6
$166-0160
Ureter stone forceps
11-774
I
6
$166-0180
Urethrotome
17-633
I
6
$166-0200
Gatherder introducer
10-678
I
6
$166-0220
Urether clamps
10-861
I
6
$166-0240
Foreign body forceps
11-774
I
6
$168-0020
Anuscope
10-156
I
5
$168-0040
Rectum specula
13-665
I
5
$168-0060
Rectum spreader
13-707
I
5
$168-0080
Proctoscope
13-126
I
5
$168-0100
Rectoscope
11-274
I
6
$168-0120
B'opsy forceps
16-270
I
6
$168-0140
Cysticu hook
12-028
I
6
$168-0160
SJction cannula
10-566
[
6
$168-0180
Hamorrhoiden-Ligator
12-335
I
6
$168-0200
Polypen-SchnOrer
13-631
I
6
$168-0220
Hemorrhoidal forceps
11-774
I
6
$170-0060
Fistel hook
13-996
J
6
$170-0080
Hook forceps
11-774
J
6
$170-0100
Cone knife
12-239
J
6
$170-0120
Myoma instruments
15-621
J
6
$170-0140
Probe excision forceps
11-774
I
6
$170-0160
Biopsy curettes
11-084
I
6
$170-0180
Vaginal specula
13-666
I
5
$170-0220
Uterus-dilatators
11-266
I
6
$170-0240
Uterus-grasping forceps
13-996
I
6
$170-0260
Uterus-Polyp forceps
11-774
I
6
$170-0280
Uterus depressors
16-486
I
6
$170-0300
Uterus curettes
11-084
I
6
$170-0320
Uterus spoon
13-508
I
6
$170-0340
U:erus probes
15-237
I
6
$170-0360
Amniotome
10-089
I
6
$170-0380
Biopsy forceps
16-270
I
6
$170-0400
Salpingograh
15-895
I
6
$170-0420
Retractor
13-373
I
6
$172-0040
Abortus spoon curette
11-084
I
6
Alig _KIl Ol-lS.doc
Seite 9 von 13
--- --------
Technische Dokumentation
Artikelnummer
Artic/e Number
Artikelbezeichnung
Descriptlon
UMDNS Code
Rev 01
Klasse
Class
Regel
Rule
1$172-0060
Pelvimeter
10-546
I
6
1$172-0080
Obsletric spoon
13-508
I
6
$172-0100
Obsletrical force ps
11-788
I
6
$172-0120
Cervical rind forceps
11-774
I
6
$172-0140
Umbilical cord c1amps
10-876
I
1
$172-0160
Obstrical hooks
12-028
I
6
$172-0180
Decapilalion hook
12-028
I
6
$172-0200
Clamp forceps
11-774
I
6
$172-0220
Cranioclasl
11-788
I
6
$172-0240
Placental Abortus forceps
11-774
I
6
$172-0260
Perforalorium
12-989
I
6
$174-0040
Hookles
13-996
I
6
$174-0060
Comedon inslrumenls
11-084
I
6
$174-0080
Lupus spoon
13-508
I
6
$174-0100
Trephines
14-146
I
6
$174-0120
Lupus curel1es
11-084
I
6
$174.0140
Probes
15.237
I
6
$174-0160
Punching set
13-233
I
6
$174-0180
S~in scissors
13-480
I
6
$174-0200
Nail scissors
13.480
I
1
$174-0220
Horny skin plane
11-179
I
1
$174-0240
Nail forceps
11-774
I
1
$174-0260
Nail file
11-701
I
1
$182-0020
Curel1es
11-084
I
6
$182.0040
Syndesmotome
13-117
I
6
$182-0060
A'Tlpulia syrringe
13-929
I
6
6
$182-0080
Moulh mirror
12-547
I
$182-0100
Teeth probe
13-117
I
6
$182-0120
Scaler
13-454
I
6
$182.0140
Scalpel handle
12-236
I
6
$182-0160
Moulh mirror
13-645
I
6
$182.0180
Rasps
13-288
I
6
$182-0200
Forceps
14-257
I
6
$182-0220
Root lever
11-504
I
6
$182-0240
Chisei
10-824
I
6
$182-0260
Tooth clamps
15-710
I
6
$182-0280
Excavalors
16-481
I
6
$182-0300
imprint spoon
16-350
I
6
$182-0320
Parodonlal-/Root
11-701
I
6
Allg _Kll 01.15.doc
file
Seite 10 von 13
Technische Dokumentation
Artikelnummer
Artiele Number
Artikelbezeichnung
Description
Rev 01
Klasse
ctass
Regel
Rute
15-226
I
6
UMDNS Code
$182-0340
Gingivectomy
$182-0360
Suction tube I canulas
10-566
I
6
$182-0380
Filling ICarrierinstrument
16-662
I
6
$188-0020
Container
16-767
I
1
$188-0025
Container single use
16-767
I
1
$188-0040
Sterilizing drums
13-730
I
1
$188-0045
Sterilizing drums
13-730
I
1
$188-0060
Sterilization trays
13-730
I
1
$DEN-0020
Crampon forceps
15-710
I
5
$DEN-0040
Punch
15-239
I
5
$DEN-0060
Stripe darner
16-667
I
5
$DEN-0080
Rasp
15-218
I
6
$DEN-0100
Contour force ps
15-710
I
5
$DEN-0120
Periodontal file
11-701
I
5
$DEN-0140
Paraontal chisei
15-211
I
5
$DEN-0180
Mouth mirror handle
12-547
I
5
$DEN-0200
Mouth mirror
12-547
I
5
$DEN-0220
Impring spoon
16-350
I
6
$DEN-0240
Soft tissue forceps
15-710
I
5
$DEN-0260
Amalgam-darner
16-179
I
5
$DEN-0280
Amalgam-Pistol
16-179
I
5
$DEN-0300
Ampulla syrringe
13-938
I
5
$DEN-0320
Mixlure spatula
15-249
I
5
$DEN-0360
Root retractor
16-480
I
6
$DEN-0380
Nerv probe
15-237
I
6
SDEN-0400
Filling instruments
16-667
I
5
SDEN-0420
Tooth forceps
14-257
I
5
SDEN-0480
Excavator
16-481
I
5
$DEN-0500
Band setter
16-667
I
5
SDEN-0520
Modelling instruments
16-667
I
5
SDEN-0540
Distal End Cutter
13-041
I
5
16-667
I
6
knife
SDEN-0560
Dental-Handinstrument,
$DEN-0580
Gigivectomy chisei
15-211
I
6
$DEN-0600
Gigivectomy knife
15-226
I
6
SDEN-0620
Band removal forceps
15-710
I
5
SDEN-0630
Hollow guttural force ps
15-710
I
5
SDEN-0640
Arrow buck forceps
15-710
I
5
SDEN-0660
Tooth probe
15-237
I
$DEN-0680
Tampon darner
16-667
I
Alig Jll
01-15.doc
others
I
I
6
5
Seite 11 von 13
Technische Dokumentation
Artikelnummer
Articfe Number
Artikelbezeichnung
Description
UMONS Code
Rev 01
Klasse
Cfass
Regel
Rufe
$DEN..Q700
Cap punch
15-711
I
5
$DEN..Q740
Nev needle punch
15-710
I
5
$DEN..Q760
Tooth punch
15-710
I
5
$DEN-0780
Root splint forceps
15-710
I
6
$DEN-0800
Coranal spreader
15-253
I
5
$DEN..Q820
Coronal opener
16-667
I
5
$DEN-0840
Coronaltaker
16-357
I
5
$DEN-0860
Band presser
16-667
I
5
$DEN-0880
Coronaltaker
forceps
15-710
I
5
$DEN-0900
Polishing instruments
16-412
I
5
$DEN-0920
Cofferdam-hole
16-651
I
6
$DEN-0940
Clam forceps
15-710
I
5
$DEN-0980
Handles
11-161
I
5
$DEN-1020
Anvil
16-195
I
5
$DEN-1040
,A.nvilband
16-195
I
5
$DEN-1060
Anvilturnbuckle
16-667
I
5
$DEN-1080
Cement spatula
13-647
I
5
$DEN-1100
Tooth cleaner
16-667
I
6
$HAN-0020
Sterilization container
13-730
I
1
$HAN-0040
Teflon container
16-767
I
1
$HAN-0060
Instrument container
16-767
I
1
$HAN-0120
Plate culling forceps
11-774
I
6
$HAN-0140
Plate bending forceps
11-774
I
6
$HAN-0160
Screwdriver
13-517
I
6
$HAN-0180
Plate holding forcpes
14-257
I
6
$HAN-0200
Drill guide
17-760
I
6
13-117
I
6
6
$HAN-0220
punch
Depth gouge
$LAP-0020
Scissor
13-484
I
$MAX-0060
Sterilization container
13-730
I
1
$MAX-0080
Instruments container
13-730
I
1
$MAX-0100
Teflon container
13-730
I
1
$MAX-0120
Drillguide
17-760
I
6
Drill hole! depth measure
instrument
13-117
I
$MAX-0140
$MAX-0180
Drill-! Screwaide
17-760
I
6
$MAX-0200
Plate-!wire culling pliers
11-933
I
6
SMAX-0220
Plate bending forceps
11-774
I
6
$MAX-0240
Flat pliers
11-774
I
Plate holding clamps
10-661
I
$MAX-0260
Alig _K11 01-15.doc
6
6
I
6
Seite 12 von :3
Technische
Artikelnummer
Artiele Number
Dokumentation
Artikelbezeichnung
Description
UMDNS Code
Rev 01
Klasse
Class
Regel
Rule
$MAX-0280
Plate holding forks
14-257
I
6
$MAX-0300
Plate holding forcpes
14-257
I
6
$MAX-0320
Screwd river
13-517
I
6
$MAX-0340
Bending template from Tin
16-645
I
6
16-645
I
$MAX-0345
Bending template fram Tin
single use
URO-0060
Liquid container
10-944
I
Alig _K11 01-15.60c
6
6
Seite 13 von 13
Překlad - Prohlášení o shodě
Hermann Medizintechnik GmbH
Wurttemberger Str. 26
785 67 Fridingen - Germany
Prohlášení o shodě
Firma:
Hermann Medizintechnik GmbH
Wurttemberger Str. 26
785 67 Fridingen – Germany
My tímto prohlašujeme na vlastní odpovědnost, že naše produkty podle přílohy I
Chirurgické nástroje třída I, viz přiložený seznam, jsou ve shodě s následující směrnicí
Evropská směrnice pro zdravotnické prostředky 93/42/EEC
Výrobce sestavil technickou dokumentaci
Uvedené produkty jsou v souladu se základními požadavky směrnice o
zdravotnických prostředcích 93/42/EEC, přílohy I a jsou proto umístěny na trh s označením CE.
Toto prohlášení je platné do 8.11.2018
Datum: 12.1.2015
Přeložil : ing. Richard Baranyk
2016
Daniela Hermann