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Cancer Antigen 72-4 Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3010679Model 1×50 tests/kitRef 3010699Model 1×100 tests/kitRef 3013898Model 2×50 tests/kit
Identity
- Trade Name
- Cancer Antigen 72-4 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 72-4 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 tests/kit EUDAMED3010679 EUDAMED1×100 tests/kit EUDAMED3010699 EUDAMED2×50 tests/kit EUDAMED3013898 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518835 EUDAMED06925794518842 EUDAMED06942202224263 EUDAMED
- Basic UDI-DI
- B-06925794518835 EUDAMEDB-06925794518842 EUDAMEDB-06942202224263 EUDAMED
- EMDN Code
- W0102030105 CANCER ANTIGEN 72-4 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
Cancer Antigen 72-4 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06925794518835 | Class IVD General | Active |
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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 a7e45423-eb3c-4086-bc51-8d07fc2edcb0 61 fields · synced Jul 29, 2026
- EUDAMED 8272e53b-ff6c-440c-a00f-59ac8cd21d2b 61 fields · synced May 17, 2026
- EUDAMED 86941757-3305-447f-8c29-06269131bbf4 61 fields · synced May 18, 2026