ec declaration of conformity

EC DECLARATION OF CONFORMITY
No.: 05 (UMDNS 11-494 -2b)
valid to 2017-03-08
Manufacturer:
Street and House No.:
Postal code and City:
State/Federal State:
BOWA-electronic GmbH & Co.KG
Heinrich-Hertz-Str. 4-10
72810 Gomaringen
Germany
This declaration of conformity is issued under our sole responsibility (manufacturer).
Object of declaration (identification of product allowing traceability):
GMDN code and name:
UMDNS code and name:
Category code and category:
Classification rule and class:
P 44680 – Universal hand-controlled electrosurgical
diathermy system handpiece, reusable
11-494
- HF-Chirurgiegerät-Adapter, Handstück
04 Electrical and mechanical medical devices
Rule 9 - Class IIb
Product name:
Model-/Order No.:
- see attached list - see attached list -
The object of the declaration described above is in conformity with the relevant Community
harmonisation legislation:
Directive(s)_Date of last revision:
CD 93/42/EEC (MD)_2007-09-21
CD 2011/65/EU (RoHS)_2011-06-08
Conformity assessment procedure:
Annex II (Full Qualtity Assurance System) of CD
93/42/EEC (MD)
Relevant harmonised standards:
DIN EN 60601-1
DIN EN 60601-2-2
DIN EN 1041
DIN EN ISO 10993-1
DIN EN ISO 14971
The notified body TUEV SUED Product Service GmbH, Ridlerstr. 65, D-80339 München,
identification number 0123, performed and issued the certificate(s):
Title of Certificate:
EC Certificate Full Quality Assurance System
Certificate No., issued on:
G1 12 02 16316 015,
Certificate EN-13485:2012/AC:2012 No.:
Q1N 13 07 16316 017, 2013-08-19, valid to 2016-02-28
Place, date of issue:
Gomaringen, 2015-07-27
Name, function and signature:
Frank Barth, Head of Quality Management
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Strasse 4-10
72810 Gomaringen | Germany
Telefon +49 (0) 7072-6002-0
Telefon +49 (0) 7072-6002-33
[email protected] | bowa.de
2012-02-24, valid to 2017-03-08
Registergericht: Tübingen HRA 381478
Geschäftsführer: Dr. Thomas Kröber
UMDNS-Code: 11-494 (Class 2b)
DIMDI-notification number:
DE/CA40/BOW-GO-007
“Electrode handle with switches”
“Elektrodenhandgriff mit Taster”
Order No.
Product name
104-045
ErgoPEN slim, 2 switches, shaft 4 mm, for Erbe, cable 4.5 m
105-045
ErgoPEN slim, 2 switches, shaft 2.4 mm, for Erbe, cable 4.5 m
110-045
ErgoPEN large, 2 switches, shaft 4 mm, for Erbe, cable 4.5 m
112-045
ErgoPEN large, 2 switches, shaft 4 mm, for Erbe-T, cable 4.5 m
120-045
JackKNIFE, 2 switches, shaft 2.4 mm, for Erbe, cable 4.5 m
120-145
JackKNIFE, 2 switches, shaft 4 mm, for Erbe, cable 4.5 m
214-045
ErgoPEN slim, 2 switches, shaft 4 mm, for Martin, cable 4.5 m
215-045
ErgoPEN slim, 2 switches, shaft 4 mm, for 3-pin, cable 4.5 m
215-145
ErgoPEN slim COMFORT, 2 switches, shaft 4 mm, for 3-pin, cable 4.5 m
218-045
ErgoPEN slim, 2 switches, shaft 2.4 mm, for 3-pin, cable 4.5 m
218-145
ErgoPEN slim, 2 switches, shaft 2.4 mm, COMFORT, cable 4.5 m
220-045
JackKNIFE, 2 switches, shaft 2.4 mm, for 3-pin, cable 4.5 m
220-145
JackKNIFE, 2 switches, shaft 4 mm, for 3-pin, cable 4.5 m
220-245
JackKNIFE, 2 switches, shaft 4 mm, for Martin, cable 4.5 m
220-345
JackKNIFE ARC 100, shaft 2.4 mm with cable for bipolar forceps 4 m
227-045
ErgoPEN large, 2 switches, shaft 4 mm, for Martin, cable 4.5 m
322-045
ErgoPEN large, 2 switches, shaft 4 mm, for 3-pin, cable 4.5 m
327-045
ErgoPEN large, 2 switches, shaft 2.4 mm, for 3-pin, cable 4.5 m
801-030
Handle, r. sw., knife, d=2.4 mm, 3-pin, 3 m, s-u, sterile (50 pcs.)
802-030
Handle, 2 sw., knife, d=2.4 mm, 3-pin, 3 m, s-u, sterile (50 pcs.)
802-031
Handle, 2 sw., d=2,4 mm, 3-pin, 3 m, s-u, sterile (50 pcs.)
802-032
SHE SHA Handle, 2 sw., knife, 3 m, s-u, sterile (10 pcs.)
932-042
Argon handle COMFORT, cable 3.5 m
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Strasse 4-10
72810 Gomaringen | Germany
Telefon +49 (0) 7072-6002-0
Telefon +49 (0) 7072-6002-33
[email protected] | bowa.de
Registergericht: Tübingen HRA 381478
Geschäftsführer: Dr. Thomas Kröber