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Dynamiker Aspergillus IgE Ab Assay (POCT Chemiluminescence)
EUDAMEDClass IVD General (EU MDR)
Ref DNK-1901-53Model 48 testsModel 24 tests
Identity
- Device Name
- Dynamiker Aspergillus IgE Ab Assay (POCT Chemiluminescence) EUDAMED
- Model / Reference
- 48 tests EUDAMEDDNK-1901-53 EUDAMED24 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930317802803 EUDAMED06930317802797 EUDAMED
- Basic UDI-DI
- B-06930317802803 EUDAMEDB-06930317802797 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dynamiker Aspergillus IgE Ab Assay (POCT Chemiluminescence) by Dynamiker Biotechnology (Tianjin) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06930317802803 | 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 (2)
- EUDAMED 5c891712-1ae7-40d4-864d-12a30bc44186 61 fields · synced Oct 6, 2026
- EUDAMED 9c1758ee-fcc5-47d3-b47f-508ece1558f9 61 fields · synced May 19, 2026