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Dynamiker Aspergillus Galactomannan Assay
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1402-1Model 96 testsRef DNK-1901-58Model 24 testsModel 48 tests
Identity
- Device Name
- Dynamiker Aspergillus Galactomannan Assay EUDAMEDDynamiker Aspergillus Galactomannan Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 96 tests EUDAMEDDNK-1402-1 EUDAMED24 tests EUDAMEDDNK-1901-58 EUDAMED48 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317800014 EUDAMED06930317820494 EUDAMED06930317839861 EUDAMED
- Basic UDI-DI
- B-06930317800014 EUDAMEDB-06930317820494 EUDAMEDB-06930317839861 EUDAMED
- EMDN Code
- W0105060301 ASPERGILLUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia 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 Aspergillus Galactomannan Assay 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-06930317800014 | 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 3e536727-c196-429d-ba03-5102460f30cc 61 fields · synced Oct 5, 2026
- EUDAMED d53493eb-9e9f-494c-aacc-8ccd6da21e88 61 fields · synced May 18, 2026
- EUDAMED 313ed26c-5a42-479f-8e89-c3dc22c95f00 61 fields · synced May 19, 2026