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Cancer Antigen (CA19-9) Chemiluminescence Quantitative Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 69543760F0001464Model 100 Tests
Identity
- Trade Name
- Cancer Antigen (CA19-9) Chemiluminescence Quantitative Immunoassay Kit EUDAMED
- Device Name
- Cancer Antigen (CA19-9) Chemiluminescence Quantitative Immunoassay Kit EUDAMED
- Model / Reference
- 100 Tests EUDAMED69543760F0001464 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954376012461 EUDAMED
- Basic UDI-DI
- B-06954376012461 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Cancer Antigen (CA19-9) Chemiluminescence Quantitative Immunoassay Kit by Beijing Leadman Biochemistry Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06954376012461 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
- EUDAMED SRN
- CN-MF-000020150
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 94022651-f0aa-4d1c-b93d-ce16674e64d9 61 fields · synced Jun 19, 2026