Agar B.H.I. (Brain Heart Infusion Agar)
by Sanimed International Impex S.A. 2 variants
Ref 40105, 30101, 20109, 10108, 101025
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 | Number594054037AGARB.H.I.1234V7 | Date6 Aug 2025 | 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- Withdrawn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
- 40105, 30101, 20109, 10108, 101025
- Primary DI / UDI-DI
- 05940540370001, 05940540371381, 05940540371435, 05940540371374, 05940540371398
- Basic UDI-DI
- 594054037AGARB.H.I.1234V7, 594054037AGARB.H.I.BHI25W, 594054037AGARB.H.I.B345YZ, 594054037AGARB.H.I.BH233W, 594054037AGARB.H.I.BHI15U
- EMDN Code
- W0104010101, W0104010206, W0104010306
- Device Class
- Class A
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000035897
Other devices from Sanimed International Impex S.A.
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