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Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)
EUDAMEDClass IVD General (EU MDR)
Ref C2KC010Ref C2KJ002
Identity
- Trade Name
- Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA) EUDAMED
- Model / Reference
- C2KC010 EUDAMEDC2KJ002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976753477861 EUDAMED06971792053410 EUDAMED
- Basic UDI-DI
- B-06976753477861 EUDAMEDB-06971792053410 EUDAMED
- EMDN Code
- W0103020503,W0105040611 EUDAMEDW0105040611 DENGUE VIRUS 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
Dengue NS1 Antigen (DEN NS1 Ag) 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-06976753477861 | 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 e5c46a12-0945-4ae7-adf3-b29ab8ce5a1c 61 fields · synced Oct 6, 2026
- EUDAMED 96c6576d-599d-46e0-8b95-3dfb279827aa 61 fields · synced May 18, 2026