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NS20 Fully Automated IHC Stainer

EUDAMED

Class A (EU MDR)

Ref 130.043.001-00Model NS40, NS20

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

Identity

Trade Name
NS20 Fully Automated IHC Stainer EUDAMED
Device Name
Fully Automated IHC Stainer EUDAMED
Model / Reference
NS40, NS20 EUDAMED
130.043.001-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06971182571432 EUDAMED
Basic UDI-DI
69711825725VY EUDAMED
Direct Marketing DI
06971182571432 EUDAMED
EMDN Code
W0202059001 IMMUNOHISTOCHEMISTRY PROCESSORS 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

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

NS20 Fully Automated IHC Stainer 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 fc1e755d-6c01-437d-b61b-09729678bab1 61 fields · synced Jun 19, 2026