Pre-Trigger Solution
by Virtue Diagnostics (Suzhou) Co., Ltd 2 variants
Ref 12001082, 12001085
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 | Number697440255CLIA_PreTriSolUG | Date14 Jul 2022 | 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- Withdrawn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
- Trade Name
- Pre-Trigger SolutionTrigger Solution
- Model / Reference
- 12001082, 12001085
- Primary DI / UDI-DI
- 06974402553058, 06974402553010
- Basic UDI-DI
- 697440255CLIA_PreTriSolUG, 697440255CLIA_TriSol8E
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000013251
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Other devices from Virtue Diagnostics (Suzhou) Co., Ltd
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