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Nucleic Acid Extraction-Purification Kit V-VI - EUDAMED Registration 06955792700741

Access comprehensive regulatory information for Nucleic Acid Extraction-Purification Kit V-VI in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06955792700741 and manufactured by Sansure Biotech Inc. in China.

This page provides complete registration details including trade name (Nucleic Acid Extraction-Purification Kit V-VI), 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.

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EUDAMED Official Data
Class A
06955792700741
No
Nucleic Acid Extraction-Purification Kit V-VI
Trade Name: Nucleic Acid Extraction-Purification Kit V-VI
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Device Description (EMDN)

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0105900101
Trade Name
Nucleic Acid Extraction-Purification Kit V-VI
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06955792700741
Basic UDI
69557927S5006E000001QJ
Version Date
February 21, 2025
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
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Gรฉnรฉral Wahis Brussels
Email
regulatory@obelis.net
Telephone
+32(2)73 25 954
Regulatory Information
Competent Authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No