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Liquid-Based Thin-layer Cytology Processor

EUDAMED

Class A (EU MDR)

Ref CP-20Model YGR-Z01、YGR-Z02、YGR-Z03、YGR-LBC-04

by Hangzhou Yiguoren Biotechnology Co., Ltd.

Identity

Trade Name
Liquid-Based Thin-layer Cytology Processor EUDAMED
Device Name
Liquid-Based Thin-layer Cytology Processor EUDAMED
Model / Reference
YGR-Z01、YGR-Z02、YGR-Z03、YGR-LBC-04 EUDAMED
CP-20 EUDAMED

Identifiers

Primary DI / UDI-DI
06970413352420 EUDAMED
Basic UDI-DI
697041335YGR2003EU8F EUDAMED
EMDN Code
W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Italy 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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Liquid-Based Thin-layer Cytology Processor by Hangzhou Yiguoren Biotechnology Co., 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

EUDAMED SRN
CN-MF-000003616
Authorised Representative
BioDomi GmbH DE-AR-000016611

Sources (1)

  • EUDAMED 530aba34-994e-4f2e-b722-bbb26f6c0056 61 fields · synced Jul 20, 2026