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Carbohydrate Antigen 19-9 (CA19-9) Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref M5402CVModel M5402CV, M5403CV, M5402CC, M5404CC, M5403CC
Identity
- Trade Name
- Carbohydrate Antigen 19-9 (CA19-9) Test Kit EUDAMED
- Device Name
- Carbohydrate Antigen 19-9 (CA19-9) Test Kit EUDAMED
- Model / Reference
- M5402CV, M5403CV, M5402CC, M5404CC, M5403CC EUDAMEDM5402CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979469760005 EUDAMED
- Basic UDI-DI
- B-06979469760005 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Carbohydrate Antigen 19-9 (CA19-9) Test Kit by Nanjing Vazyme Medical Technology 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-06979469760005 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED a89bb2cd-a04e-4f3f-a31c-d616a347b24e 61 fields · synced Jun 18, 2026