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Papanicolaou Ea50m Stain (modified) - 1l

EUDAMED

Class A (EU MDR)

Ref RBA-0101-00B

by CellPath Ltd

Identity

Trade Name
PAPANICOLAOU EA50M STAIN (MODIFIED) - 1L EUDAMED
Device Name
EA50 EUDAMED
Model / Reference
RBA-0101-00B EUDAMED

Identifiers

Primary DI / UDI-DI
05056256108583 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 Ea50m Stain (modified) - 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

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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 c72f9930-46f7-441c-926d-6220777a2f13 61 fields · synced Jun 19, 2026