Precision Medical Continuous Vacuum Regulator - Manual (Page 12)

DECLARATION OF CONFORMITY
Precision medical, Inc
300 Held Drive
Northampton PA 18067, USA
Emergo Europe (European Office)
molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
0473
Vacuum Regulators:
Pm3000E, Pm3000DE, Pm3000DEHV, Pm3100E, Pm3100DE,
Pm3100DE-mG, Pm3100DEHV, Pm3100DEIN, Pm3100EHV,
Pm3100EHV-Y, Pm3100EIN, Pm3200E, Pm3200E-Y,
Pm3200E3, Pm3500E, Pm3500E-mG, Pm3500DE,
Pm3500DE-LB, Pm3600E, Pm3600DE
Classification: IIa
Classification criteria: Clause 3.2 Rule 11 of Annex Ix of mDD
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 and Directive 2007/47/EC on medical devices.
We certify that the production quality system conforms to the relevant provisions
of the aforementioned legislation, and the result entitles the organization to use
the CE 0473 marking on those products listed above.
Applied Standards: BS EN 1041, EN ISO 10079-3, EN ISO 14971, ISO 15223-1
Notified Body:
AmTAC Certification Services Limited 0473
Address: Davy Avenue knowlhill milton keynes mk5 8NL, Uk
Certification Registration No’s: 1126 CE
Date of Expiry: 03 August 2017
Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 04 August 2012 to Date of Expiry
Manufacture Representative: Quality manager
Position:
Quality Systems/ISO Representative
Date of Issue: 04 August 2012
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503443 Rev12 09/28/12 (?m) P
rinted in
USA