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Dynamiker Cryptococcus neoformans Antigen Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-62Model 48 testsModel 24 testsModel 48 tests/kit Model 24 tests/kit
Identity
- Device Name
- Dynamiker Cryptococcus neoformans Antigen Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 48 tests EUDAMEDDNK-1901-62 EUDAMED24 tests EUDAMED48 tests/kit EUDAMED24 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317873414 EUDAMED06930317841437 EUDAMED06930317865518 EUDAMED06930317870284 EUDAMED
- Basic UDI-DI
- B-06930317873414 EUDAMEDB-06930317841437 EUDAMEDB-06930317865518 EUDAMEDB-06930317870284 EUDAMED
- EMDN Code
- W0105060303 CRYPTOCOCCUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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 Cryptococcus neoformans Antigen Assay (POCT Chemiluminescence) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in…
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-06930317873414 | 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 (4)
- EUDAMED df30fe3e-05f3-4269-b7eb-3cf824ddbf96 61 fields · synced Oct 6, 2026
- EUDAMED 26f155d2-c994-4dec-8da5-fb69c43e25de 61 fields · synced May 18, 2026
- EUDAMED 4df457a4-a796-41a3-ae51-710c568cc46f 61 fields · synced May 18, 2026
- EUDAMED bd0dac66-0208-4f0f-9792-2437e827a5f5 61 fields · synced May 18, 2026