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Squamous Cell Carcinoma Antigen（SCC）Assay Kit (Chemiluminescent Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 100 tests/kitRef DD0401Model 2×50 test/box Calibrator:0.5mL×2

by Shenzhen AmTech Bioengineering Ltd., Inc.

Identity

Trade Name
Squamous Cell Carcinoma Antigen (SCC) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Device Name
Squamous Cell Carcinoma Antigen（SCC）Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Squamous Cell Carcinoma Antigen (SCC) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Model / Reference
100 tests/kit EUDAMED
2×50 test/box Calibrator:0.5mL×2 EUDAMED
DD0401 EUDAMED

Identifiers

Primary DI / UDI-DI
06937287300414 EUDAMED
06970522642382 EUDAMED
Basic UDI-DI
B-06937287300414 EUDAMED
B-06970522642382 EUDAMED
EMDN Code
W0102030116 SQUAMOUS CELL CARCINOMA ANTIGEN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED
Spain 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

Squamous Cell Carcinoma Antigen（SCC）Assay Kit (Chemiluminescent Immunoassay) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen AmTech Bioengineering Ltd., Inc.
EUDAMED SRN
CN-MF-000043067
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 679d9d22-7d3b-4514-b9ab-425438cc6f00 61 fields · synced Jul 28, 2026
  • EUDAMED 5a15775c-6a33-45f2-beda-d9410d601fd6 61 fields · synced Jul 28, 2026