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Embedding Cassette

EUDAMED

Class A (EU MDR)

Ref C-1-00Model C-0A-00, C-0B-01, C-0B-00, C-1-00, C-1-02, C-1-01, C00, C01, C02, C03

by Dakewe (Shenzhen) Medical Equipment Co., Ltd.

Identity

Trade Name
Embedding Cassette EUDAMED
Device Name
Embedding Cassette EUDAMED
Model / Reference
C-0A-00, C-0B-01, C-0B-00, C-1-00, C-1-02, C-1-01, C00, C01, C02, C03 EUDAMED
C-1-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06971182571043 EUDAMED
Basic UDI-DI
69711825713VR EUDAMED
EMDN Code
W05020106 BIOPSY CARTRIDGES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Greece 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

Embedding Cassette by Dakewe (Shenzhen) Medical Equipment 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-000009696
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 57fdfc2f-271d-4718-9570-d5e97a19d4bd 61 fields · synced Jun 18, 2026