english - erbrich instrumente GmbH

CE-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 including the
directive 2007/47/EC
for the product categories
Skelet Implants
Wires, Nails, Plates, Screws, Staples;
Orth. –Fixation Systems, Fracture Spine
(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: 05-306-719
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
Orthopedic External Fixation Systems, Spinal IIb Rule 8 16-046
Orthopedic External Fixation Systems, Fracture IIb Rule 8 15-767
Orthopedic External Fixation Systems, Other IIb Rule 8 16-059
Nails Bones IIb Rule 8 16-078
Plates Bones IIb Rule 8 13-050
Screws Bones IIb Rule 8 16-101
Staples Bones IIb Rule 8 16-103
Wires Bones IIb Rule 8 16-104
Company name: erbrich-instrumente GmbH
Applies to certificate: 05-306-719
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 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