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15. CONFORMITEITSVERKLARING
Declaration of Conformity
Classification:
Classification criteria:
We hereby declare that an examination of the under mentioned production quality assurance system has been carried out
following the requirements of the UK national legislation to which the undersigned is subjected, transposing Annex II, 3 of
the Directive 93/42/EEC as amended by all subsequent directives.
Notified Body:
Certification Registration No's:
Devices already manufactured:
Validity of DOC:
Manufacture Representative:
Position:
Date of Issue:
Precision Medical Inc.
300 Held Drive
Northampton Pa 18067 USA
Emergo Europe (European Office)
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Phone: +31 (0)70.345.8570
Fax: +31 (0) 70.346.7299
EasyPulse Flow Conserver / Flowmeter 19MFA
IIa
Clause 3.2 Rule 11 of Annex IX of MDD
10055119
SN traceability via Device History Records
6 February 2018 to Date of Expiry
James Parker
Manager, Quality System/ISO Representative
6 February 2018
Zénobe Grammestraat 34
2600 Berchem, België
0088
1330 Enclave Pkwy, Suite 200
Houston, TX 77077
Date of Expiry: 5 February 2023
Signature:
+32 3 265 25 91
info@oxypoint.eu
Digitally signed by
James Parker
Date: 2018.02.09
08:08:14 -05'00'
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