iVYCHECK GIP Stool, 25T
Ref KT-5737Model iVYCHECK GIP Stool, 25T
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08437021758023 | Date7 Mar 2024 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- iVYCHECK GIP Stool, 25T, KT-5737
- Primary DI / UDI-DI
- 08437021758023
- Basic UDI-DI
- B-08437021758023
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000001009
Other devices from Biomedal, S.L.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No