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Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref 3021015Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit
Identity
- Trade Name
- Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3021015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794589446 EUDAMED
- Basic UDI-DI
- 69257945W0102030103R0LV EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69257945W0102030103R0LV | Class C | 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 (1)
- EUDAMED 0980d8af-b319-4dd6-a7de-9e5c38d00208 61 fields · synced Jun 18, 2026