english - erbrich instrumente GmbH

EC-Certificate
Full quality assurance system
The conformity assessment body for medical devices of Swiss TS
Technical Services AG hereby certifies that :
erbrich-instrumente GmbH
Eugenstrasse 33
D-78532 Tuttlingen
has introduced and applies a full quality assurance system
according to annex II.3 of directive 93/42 EEC.
for the product categories
HF-Instruments, units and accessories for Surgery,
Laparoscopy, Arthroscopy; Disposable Scalpels, Scalpel
Blades sterile; Rib Spreaders; Aspiration Cannulas
(refer to product list)
The full quality assurance system covers design, manufacturing and final
inspection of the products according to the requirements of annex II.3 of
the directive 93/42 EEC. The quality assurance system is regularly
controlled by Swiss TS Technical Services AG according to annex II.5.
Registration number: 05-306-720
First certification: 08.11.2005
Valid until: 07.11.2014
CE marking of conformity:
Heinrich A. Bieler
Head of the certification body
Wallisellen, 02.11.2011
Notified Body 1253 of
Swiss TS Technical Services AG
Richtistrasse 15
CH-8304 Wallisellen
Swiss TS, a company of SVTI and TÜV SÜD
SWISS
C E R T I F I C A T I O N
SCESm013

Product list
To CE-Certificate –
Production Quality assurance
Product Class Rule UMDNS
Rib Spreaders IIa Rule 6 13-709
Sterile Scalpels IIa Rule 6 12-252
Cannulas, other IIa Rule 6 15-206
Suction-Irrigation Units incl Accessoires IIa Rule 6 13-845
HF-Instruments, units and accessories IIb Rule 5 11-502
HF-Electrodes IIb Rule 5 15-579
Bipolar Forceps IIb Rule 5 11-502
Company name: erbrich-instrumente GmbH
Applies to certificate: 05-306-720
First certification: 08.11.2005
Valid until: 07.11.2014
CE marking of conformity:
Heinrich A. Bieler
Wallisellen, 02.11.2011
Notified Body CE 1253 of
Swiss TS Technical Services AG
Richtistrasse 15
CH-8304 Wallisellen
Swiss TS, a company of SVTI and TÜV SÜD
SWISS
C E R T I F I C A T I O N
SCESm013