We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
You are on page 1/ 1
FULL QUALITY ASSURANCE SYSTEM APPROVAL
CERTIFICATE
(Annex II of the Directive 93/42/EEC on Medical Devices)
No, 41313831 4
‘We hereby declare that an examination of the under mentioned full quality assurance
system has been carried out following the requirements of the national legislation LVES
2003:11 to which the undersigned is subjected, transposing Annex II (with the exemption of
section 4) of the Directive 93/42/BEC on medical devices. We certify that the full quality
assurance system conforms with, the relevant provisions of the aforementioned legislation.
Manufacturer:
77-19 Terrace Hall Avenue 4
Burlington, MA01803
USA
| 4
Product category: Portable Medical Ultrasound Imaging Equipment
5
Date of expiry: 22 Merch 2011
‘The Certificate is valid for the devices which are stated in the present MDD — Product list
Stockholm Intertek Semko AB
7 Sune 2006 Noitgd Body MDD 3
‘The original certificate issued on
22 March 2001 farie Olsson
Certification Managér MDD
Inverts Semko AB iss Notified Body ssenrding tothe Diretve 93/42/EEC on medial dovoes, with ientfonion umber 0413,
ETL SEMKO