Chromogenic Strepto B/Columbia LAB-AGAR™ + 5% BS
Ref PD 016
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 | Number59026439APD016DH 05902643930964 | Date25 Nov 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- Withdrawn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
- PD 016
- Primary DI / UDI-DI
- 05902643930964
- Basic UDI-DI
- 59026439APD016DH
- EMDN Code
- W0104010101 Dehydrated culture media (dcm)
- Device Class
- Class A
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000039473
Other devices from BioMaxima Spółka Akcyjna
Properties
Other properties (10)
- 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
- New Device: No