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Dynamiker Candida Mannan Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-59Model 24 testsModel 24 tests/kit Ref DNK-1901-28Model 100 testsRef DNK-1403-1Model 96 testsModel 48 tests/kit Model 48 tests
Identity
- Device Name
- Dynamiker Candida Mannan Assay (POCT Chemiluminescence) EUDAMEDDynamiker Candida Mannan Assay(Chemiluminescence) EUDAMEDDynamiker Candida Mannan Assay EUDAMED
- Model / Reference
- 24 tests EUDAMEDDNK-1901-59 EUDAMED24 tests/kit EUDAMED100 tests EUDAMEDDNK-1901-28 EUDAMED96 tests EUDAMEDDNK-1403-1 EUDAMED48 tests/kit EUDAMED48 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317845107 EUDAMED06930317829961 EUDAMED06930317802292 EUDAMED06930317802155 EUDAMED06930317805873 EUDAMED06930317861619 EUDAMED
- Basic UDI-DI
- B-06930317845107 EUDAMEDB-06930317829961 EUDAMEDB-06930317802292 EUDAMEDB-06930317802155 EUDAMEDB-06930317805873 EUDAMEDB-06930317861619 EUDAMED
- EMDN Code
- W0105060302 CANDIDA ALBICANS 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 Candida Mannan 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-06930317845107 | 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 (6)
- EUDAMED 4bf10378-81fb-40e9-81c0-3685ab45591f 61 fields · synced Oct 5, 2026
- EUDAMED 5c9b2733-a70c-4518-956c-cf30510f195b 61 fields · synced May 17, 2026
- EUDAMED 8598be0a-d91b-496b-9414-f61de9ddf86a 61 fields · synced May 17, 2026
- EUDAMED 53354bd5-f787-4342-baa4-2a7748fbaaa9 61 fields · synced May 18, 2026
- EUDAMED 1c2e1b98-aed8-4dbc-aec7-82a7e18147ba 61 fields · synced May 18, 2026
- EUDAMED 5ce5ab5f-9c72-48f2-b65b-2afec6d0733a 61 fields · synced May 19, 2026