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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
Whole-body plethysmograph
M
ODEL NUMBER
PDT-111/p
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 Garuen Stein
EC
CERTIFICATES
ISO 13485:2003
CE 0197
Safety test
EMC test
M
AIN ACCESSORIES
PCS-3000
PBF-30
MPA-30
B
, 11 M
2007/
UDAPEST
AY
........................
Kornél NAGY, Mr
Quality Assurance Manager
C
ONFORMITY
EC Declaration of Conformity
Tel:
Fax:
http:
Email:
Registration Nr:
SX 600174060001
Report Nr:
28202723002
Report Nr:
28203472001
Report Nr:
28203473001
Calibration syringe
Bacterial filter
Mouth piece
Piston Atmungsdiagnostik - 111
+36-1-275-0033
+36-1-275-0034
www.pistonmedical.com
info@pistonmedical.com
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