Cellstor - 10l Polycube - 10% Neutral Buffered Formalin
by CellPath Ltd EUDAMED
Active
Ref BAF-0010-10S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number05056256BAF002VY | Date8 Aug 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- 10% Neutral Buffered Formalin
- Model / Reference
- BAF-0010-10S
- Primary DI / UDI-DI
- 05056256110524
- Basic UDI-DI
- 05056256BAF002VY
- EMDN Code
- W01030705 Fixing reagents (histology/cytology)
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000022744
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from CellPath Ltd
Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No