Histogen 10% Neutral Buffered Formalin
by Serosep Limited Ireland EUDAMED
Ref Histogen 5000, Histogen 350, Histogen 1000, Histogen 125, Histogen 180 EMDN W05019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0539151387HISTZN | Date26 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- HistoPot 10% Neutral Buffered Formalin
- Model / Reference
- Histogen 5000, Histogen 350, Histogen 1000, Histogen 125, Histogen 180
- Primary DI / UDI-DI
- 05391513871108, 05391513871061, 05391513871085, 05391513871030, 05391513871047
- Basic UDI-DI
- 0539151387HISTZN
- Direct Marketing DI
- 0539151387110805391513871061053915138710850539151387103005391513871047
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- Market of Registration
- SpainIreland
Manufacturer details
- EUDAMED SRN
- IE-MF-000020322
Other devices from Serosep, Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (5)
- EUDAMED 1dea1754-7f7a-4789-8bc1-d3d96ca601ec
- EUDAMED 05391513871061|0539151387HISTZN
- EUDAMED 05391513871085|0539151387HISTZN
- EUDAMED 05391513871030|0539151387HISTZN
- EUDAMED 05391513871047|0539151387HISTZN