← Back to catalogue
Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-55Model 24 tests/kitModel 48 tests/kit
Identity
- Device Name
- Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 24 tests/kit EUDAMEDDNK-1901-55 EUDAMED48 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317807747 EUDAMED06930317870048 EUDAMED
- Basic UDI-DI
- B-06930317807747 EUDAMEDB-06930317870048 EUDAMED
- EMDN Code
- W0105040604 INFLUENZA & PARA INFLUENZA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Dynamiker Influenza A Antigen Assay (POCT Chemiluminescence) by Dynamiker Biotechnology (Tianjin) 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-06930317807747 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 8dfc4225-2305-45d0-98cb-4983562e6e9e 61 fields · synced Jul 16, 2026
- EUDAMED a2cfef43-51f8-4fe5-b73a-8d2a7dab434a 61 fields · synced May 19, 2026