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06955792700789

Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)

Sansure Biotech Inc.·Class A·EU EUDAMED·Trade name: Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)No
Device classification
Risk class
Class A
CND nomenclatures code
W0105900101
Trade name
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06955792700789
Basic UDI
69557927S1001E000001HP
Version date
February 18, 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
Name
Obelis s.a.
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Général 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
Device description (EMDN)

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

About this record

Access comprehensive regulatory information for Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) 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 06955792700789 and manufactured by Sansure Biotech Inc. in China.

This page provides complete registration details including trade name (Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method)), 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.