GS1200-9015-F-B
Ref GS1200-9015-F-BModel GS1200-B
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 | Number805663343A0004VD 80566334301368 | Date22 May 2026 | 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- Withdrawn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
- Model / Reference
- GS1200-B, GS1200-9015-F-B
- Primary DI / UDI-DI
- 80566334301368
- Basic UDI-DI
- 805663343A0004VD
- Direct Marketing DI
- 80566334301368
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000054807
Other devices from Gruppo Strola srl
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No