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Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-61Model 48 tests/kit Model 24 tests/kit Model 48 tests
Identity
- Device Name
- Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMEDDNK-1901-61 EUDAMED24 tests/kit EUDAMED48 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317819153 EUDAMED06930317842236 EUDAMED06930317898776 EUDAMED
- Basic UDI-DI
- B-06930317819153 EUDAMEDB-06930317842236 EUDAMEDB-06930317898776 EUDAMED
- EMDN Code
- W0105060302 CANDIDA ALBICANS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
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 Candida albicans IgG 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-06930317819153 | 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 d8b65f81-204a-426e-a358-89dc2f7cc94b 61 fields · synced Oct 6, 2026
- EUDAMED 9d8dbc60-d038-44bd-8d63-d5ac4295b0d5 61 fields · synced May 18, 2026
- EUDAMED b5b3b32a-f5cc-4f2e-846f-887cfdcbe7f1 61 fields · synced May 18, 2026