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Papanicolaou Ea50 Stain (ortho) - 1l
EUDAMEDClass A (EU MDR)
Ref RBA-4212-00CRef RBA-4212-00A
by CellPath Ltd
Identity
- Trade Name
- PAPANICOLAOU EA50 STAIN (ORTHO) - 1L EUDAMED
- Device Name
- EA50 EUDAMED
- Model / Reference
- RBA-4212-00C EUDAMEDRBA-4212-00A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256108569 EUDAMED05056256113150 EUDAMED
- Basic UDI-DI
- 05056256RBA0013R EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (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
Papanicolaou Ea50 Stain (ortho) - 1l 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 | 05056256RBA0013R | 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 (2)
- EUDAMED 62524c0f-bc6f-45d6-8159-9663be92ce05 61 fields · synced Oct 6, 2026
- EUDAMED 48b6ce05-7c95-4e54-a448-4013f7732ae4 61 fields · synced May 19, 2026