Pure Global

Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP) - EUDAMED Registration 06955792743557

Access comprehensive regulatory information for Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP) 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 06955792743557 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
IVD General
06955792743557
No
Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP)
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

VIROLOGY - NA REAGENTS - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105040599
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06955792743557
Basic UDI
B-06955792743557
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 FriedlebenstraรŸe 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
Yes