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CA15-3 Detection Kit (Immunofluorescence Chromatography)
EUDAMEDClass IVD General (EU MDR)
Ref GKPD186
Identity
- Trade Name
- CA15-3 Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Device Name
- CA15-3 Detection Kit (Immunofluorescence Chromatography) EUDAMED
- Model / Reference
- GKPD186 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GKPD186Y2 EUDAMED
- Basic UDI-DI
- B-GKPD186Y2 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
CA15-3 Detection Kit (Immunofluorescence Chromatography) by Dezhou Guoke 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-GKPD186Y2 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1b438353-ccc8-4c38-9456-1e7a856a7e7a 61 fields · synced Jun 18, 2026