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Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-2105-1Model 20 testsRef DNK-1425-5NModel 5 tests/kitRef DNK-1425-1
Identity
- Device Name
- Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva) EUDAMEDDynamiker SARS-CoV-2 Ag Rapid Test EUDAMED
- Model / Reference
- 20 tests EUDAMEDDNK-2105-1 EUDAMED5 tests/kit EUDAMEDDNK-1425-5N EUDAMEDDNK-1425-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317801318 EUDAMED06930317800663 EUDAMED06930317801301 EUDAMED
- Basic UDI-DI
- B-06930317801318 EUDAMEDB-06930317800663 EUDAMEDB-06930317801301 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD devices for self-testing EUDAMED
- Market of Registration
- Portugal EUDAMEDPoland EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva) 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-06930317801318 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001133
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 19b50ba4-fede-49ff-8e61-eee065055e65 61 fields · synced Oct 6, 2026
- EUDAMED 063842da-ff17-425f-8428-59e0f3955af0 61 fields · synced May 16, 2026
- EUDAMED 03e927bc-cd33-4f36-8d6e-51cc7f18ccf0 61 fields · synced May 19, 2026