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Papanicolaou Ea50m Stain (modified) - 1l

EUDAMED

Class A (EU MDR)

Ref RBA-0101-00ARef RBA-0101-00D

by CellPath Ltd

Identity

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

Identifiers

Primary DI / UDI-DI
05056256113136 EUDAMED
05056256108606 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 (2)

  • EUDAMED fdf0cc4e-c4b6-40b5-8d6f-ee921475e4e9 61 fields · synced Sep 17, 2026
  • EUDAMED c7ecb55d-4df4-495b-b508-5f37bb161731 61 fields · synced May 18, 2026