Test Rapid H. Pylori Antigen Caseta(Scaun)
Ref VT-HPG-25
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number5944759080VTHPG25STO1B6H5 05944759080003 | Date3 Oct 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Helicobacter Pylori AG Rapid Test Cassette (Feces)
- Model / Reference
- VT-HPG-25
- Primary DI / UDI-DI
- 05944759080003
- Basic UDI-DI
- 5944759080VTHPG25STO1B6H5
- EMDN Code
- W0105010401 H. pylori antigen detection
- Device Class
- Class B
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000010877
Other devices from VitroBioChem SRL
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No