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
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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

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CE Marking Conformity
| Product Classification: | In Vitro Diagnostic Medical Devices
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| Category: | Common/Others IVD
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| ISO 13485:2003 Certificate: | Click here to view the certificate.
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| 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.
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| Represented by Wellkang since: |
4/June/2009
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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
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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
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