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Dynamiker Aspergillus fumigatus IgG Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-60Model 48 testsModel 48 tests/kit Model 24 tests/kit Model 24 tests
Identity
- Device Name
- Dynamiker Aspergillus fumigatus IgG Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 48 tests EUDAMEDDNK-1901-60 EUDAMED48 tests/kit EUDAMED24 tests/kit EUDAMED24 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317848719 EUDAMED06930317826205 EUDAMED06930317886568 EUDAMED06930317887145 EUDAMED
- Basic UDI-DI
- B-06930317848719 EUDAMEDB-06930317826205 EUDAMEDB-06930317886568 EUDAMEDB-06930317887145 EUDAMED
- EMDN Code
- W0105060301 ASPERGILLUS 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 Aspergillus fumigatus 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-06930317848719 | 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 b532aea7-1149-4174-a9bd-fd7f4042eb56 61 fields · synced Oct 6, 2026
- EUDAMED 5461f576-b94e-4277-9b57-8efff8159d64 61 fields · synced May 17, 2026
- EUDAMED b532aea7-1149-4174-a9bd-fd7f4042eb56 61 fields · synced May 19, 2026
- EUDAMED b2715dfb-ffa7-463b-bf9c-7d096bbe61f9 61 fields · synced May 19, 2026