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GynoPrep Verdünnungsflüssigkeit 30 ml

EUDAMED

Class A (EU MDR)

Ref 353-1-0

by Tharmac GmbH

Identity

Trade Name
GynoPrep Verdünnungsflüssigkeit 30 ml EUDAMED
Device Name
GynoPrep® EUDAMED
Model / Reference
353-1-0 EUDAMED

Identifiers

Primary DI / UDI-DI
04262458250024 EUDAMED
Basic UDI-DI
426245825GP1G9 EUDAMED
EMDN Code
W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

GynoPrep Verdünnungsflüssigkeit 30 ml by Tharmac GmbH — 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
Tharmac GmbH
EUDAMED SRN
DE-MF-000039165

Sources (1)

  • EUDAMED 8b1bce5f-f747-4c4d-b530-8eb608612bf3 61 fields · synced Jul 10, 2026