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CA15-3 Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52026235
Identity
- Trade Name
- CA15-3 Test Kit (Immunofluorescence) EUDAMED
- Device Name
- CA15-3 Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 52026235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334817918 EUDAMED
- Basic UDI-DI
- B-06950334817918 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
CA15-3 Test Kit (Immunofluorescence) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06950334817918 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED bd012d68-bbc9-42b2-8e3a-c89d0d7f58c8 61 fields · synced Jul 8, 2026