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EUDAMED registration 06955792743533No

15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Sansure Biotech Inc.IVD GeneralEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0105041002
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06955792743533
Basic UDI
B-06955792743533
Version date
October 07, 2023
Manufacturer last update
June 07, 2023
Active status
No
Manufacturer
Manufacturer name
Sansure Biotech Inc.
Country
China
Country type
NON_EU
Address
No.680 Lusong Road, Yuelu District Changsha, Hunan Province
Email
info@sansure.com.cn
Authorized representative
Name
OSEN
SRN
DE-AR-000023626
Country
Germany
Address
18 Friedlebenstraße Frankfurt am Main
Email
wangsheng@osenn.de
Regulatory information
Competent authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SCREENING HIGH-RISK HPV - NA REAGENTS

About this record

Access comprehensive regulatory information for 15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06955792743533 and manufactured by Sansure Biotech Inc. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.