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E-Cadherin Antibody Reagent (Immunohistochemistry)

EUDAMED

Class IVD General (EU MDR)

Ref RMB1A018

by Shenzhen Dartmon Biotechnology Co., Ltd.

Identity

Trade Name
E-Cadherin Antibody Reagent (Immunohistochemistry) EUDAMED
Device Name
E-Cadherin Antibody Reagent (Immunohistochemistry) EUDAMED
Model / Reference
RMB1A018 EUDAMED

Identifiers

Primary DI / UDI-DI
06927210901856 EUDAMED
Basic UDI-DI
B-06927210901856 EUDAMED
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Greece EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

E-Cadherin Antibody Reagent (Immunohistochemistry) by Shenzhen Dartmon Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000019183
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 0316f2ba-087c-4b0e-b2c0-c05cf4d8dcd9 61 fields · synced Oct 8, 2026