Nucleic acid extraction (DNA) or purification kit(Magnetic beads method)
by Sansure Biotech Inc. 2 variants
Ref S10012E-96Model S10012E
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69557927S10012E00001G9 06955792713178 | Date1 Apr 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)
- Model / Reference
- S10012E, S10012E-96
- Primary DI / UDI-DI
- 06955792713178
- Basic UDI-DI
- 69557927S10012E00001G9
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000011392
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Sansure Biotech Inc.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No