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Cellstor – 20l – 100% Neutral Buffered Formalin Concentrate
EUDAMEDClass A (EU MDR)
Ref CHE/BAF-0099-20A
by CellPath Ltd
Identity
- Trade Name
- CELLSTOR – 20L – 100% NEUTRAL BUFFERED FORMALIN CONCENTRATE EUDAMED
- Device Name
- 100% NEUTRAL BUFFERED FORMALIN EUDAMED
- Model / Reference
- CHE/BAF-0099-20A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256123135 EUDAMED
- Basic UDI-DI
- 05060470BAF005R5 EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cellstor – 20l – 100% Neutral Buffered Formalin Concentrate by CellPath Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 05060470BAF005R5 | Class A | Active |
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Manufacturer
- Manufacturer
- CellPath Ltd
- EUDAMED SRN
- GB-MF-000022744
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ae7e8a57-3a83-47e2-9c6d-fa48b53b6fc5 61 fields · synced Jul 9, 2026