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PISTON Ltd.
1121 Budapest
Pihenő u. 1. C pavilon
HUNGARY
EC D
ECLARATION OF
M
ANUFACTURER
Piston Ltd.
Hungary, H-1121, Budapest, Pihenő u. 1/c
P
RODUCT
Calibration Syringe for spirometers
M
ODEL NUMBER
PCS-3000
C
LASSIFICATION
Class IIa
Council Directive 93/42/EEC of MDD, Annex V, Article 3
D
ECLARATION
We herewith declare that the above mentioned products meet the provision
of the Council Directive 93/42/EEC for medical devices. All supporting
documentation is retained under the premises of the manufacturer
S
TANDARDS APPLIED
EN 60601-1
EN 60601-1-2
EN 30993-1
EN 980
EN 1441
N
B
OTIFIED
ODY
TÜV Rheinland Product Safety GmbH
Germany, D-51105 Köln, Am Grauen Stein
EC
CERTIFICATES
ISO 13485:2003
CE 0197
TH
B
, 12
J
2007
UDAPEST
UNE
........................
Kornél NAGY, Mr
Quality Assurance Manager
C
ONFORMITY
EC Declaration of Conformity
Tel:
Fax:
http:
Email:
Registration Nr:
SX 600174060001
Report Nr:
28202723002
Registration Nr:
HD 2111265 01
Report Nr:
C 2192133 E 01
Piston Atmungsdiagnostik - 114
+36-1-275-0033
+36-1-275-0034
www.pistonmedical.com
info@pistonmedical.com
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