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Carbohydrate Antigen 19-9 (CA19-9) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KH020Ref C2KA003
Identity
- Trade Name
- Carbohydrate Antigen 19-9 (CA19-9) Assay Reagent Kit (CMIA) EUDAMEDCarbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA) EUDAMED
- Model / Reference
- C2KH020 EUDAMEDC2KA003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753470855 EUDAMED06971792054417 EUDAMED
- Basic UDI-DI
- B-06976753470855 EUDAMEDB-06971792054417 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Carbohydrate Antigen 19-9 (CA19-9) Assay Reagent Kit (CMIA) by Hangzhou Cybereagen Biotech 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-06976753470855 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000037850
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 11196e2a-180d-4e1c-b444-4fc2cd7fd205 61 fields · synced Oct 6, 2026
- EUDAMED e534a949-72b6-4e3b-818c-3cbcea00b81e 61 fields · synced May 18, 2026