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Calcitonin Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3010672Model 1×50 Tests/kitRef 3010692Model 1×100 Tests/kitRef 3013888Model 2×50 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Calcitonin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Calcitonin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
1×50 Tests/kit EUDAMED
3010672 EUDAMED
1×100 Tests/kit EUDAMED
3010692 EUDAMED
2×50 Tests/kit EUDAMED
3013888 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794518163 EUDAMED
06925794518170 EUDAMED
06942202223853 EUDAMED
Basic UDI-DI
B-06925794518163 EUDAMED
B-06925794518170 EUDAMED
B-06942202223853 EUDAMED
EMDN Code
W0102060301 CALCITONIN EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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

Calcitonin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (3)

  • EUDAMED 29ac2fa4-5637-4ec4-be32-238a8b26612a 61 fields · synced Jul 14, 2026
  • EUDAMED 856be834-3ae3-4b16-8147-66a272dab9b8 61 fields · synced May 17, 2026
  • EUDAMED 6067104a-3492-4a2e-9700-d84fff951765 61 fields · synced May 17, 2026