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Model:WPC,Specifications:10mL×2

EUDAMED

Class A (EU MDR)

Ref 6600-PA00069Model DIFF、RET、WNB、PLT、WPC

by Shenzhen CoooSeee Biomedical Co., Ltd.

Identity

Trade Name
Model:WPC,Specifications:10mL×2 EUDAMED
Device Name
Hematology Analyzer Dye EUDAMED
Model / Reference
DIFF、RET、WNB、PLT、WPC EUDAMED
6600-PA00069 EUDAMED

Identifiers

Primary DI / UDI-DI
06978066774866 EUDAMED
Basic UDI-DI
697806677SE003NS EUDAMED
EMDN Code
W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) 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

Yes

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

Model:WPC,Specifications:10mL×2 by Shenzhen CoooSeee Biomedical 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-000045646
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 4d6a0e7a-c1dc-4b47-af59-1adfcf95f6bc 61 fields · synced Jul 10, 2026