Sample Release Reagent
by Sansure Biotech Inc. EUDAMED
Active
Ref S1013E-48Model S1013E
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69557927S1013E000001KL | Date1 Apr 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- S1013E, S1013E-48
- Primary DI / UDI-DI
- 06955792713482
- Basic UDI-DI
- 69557927S1013E000001KL
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- France
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