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CE Marking
Authorized Representative for
  Agnitio Science & Technology, Inc.
Medical Devices (IVD)
 (Annual service renewal needed by: 3rd May 2012) 

| Products | CE Marking | Authorized Representative | Manufacturer | Importer/Distributor |


List of Products

Agnitio BioIC Analyzer (Model: BA-G2000)

BioIC Allergen Specific IgE Detection Kit (AB 20, AC20)


Please learn more about the products at



CE Marking Conformity

Product Classification:In Vitro Diagnostic Medical Devices
Category:Common/Others IVD
ISO 13485:2003 Certificate:Click here to view the certificate.
Conformity Module:Module A (EC declaration of conformity)
(Annex III, except point 6, Directive 98/79/EC)
Lead Competent Body:UK Medicines & Healthcare Products Regulatory Agency
Product Registration Ref. No.:IVD000524
Click here to view the certificate.
Represented by Wellkang since: 4/June/2009



Authorized Representative
in the European Economic Area (incl. European Union and EFTA member states):

Wellkang Ltd (trading/as Wellkang Tech Consulting)
Suite B, 29 Harley Street
LONDON W1G 9QR, United Kingdom
Tels: +44(20)30869438/32876300     Fax: +44(20)76811874
Web: www.CE-marking.eu   www.CE-marking.com    www.wellkang.com



Manufacturer

Agnitio Science & Technology, Inc.
1F, No.7 Industry E. Rd. IX.
Hsinchu Science Park,
Hsinchu 30075
TAIWAN (ROC)
Tel: +886-3-5631088
Fax +886-3-5790111
Web: www.agnitiost.com



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Last updated on 15/April/2011