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Hyaluronic Acid（HA）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoa…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1075-2）Model 100 Tests/kitRef 200 Tests/kit（DR1075-3）Model 200 Tests/kitRef 50 Tests/kit（DR1075-1）Model 50 Tests/kit
Identity
- Trade Name
- Hyaluronic Acid（HA）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Hyaluronic Acid（HA）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1075-2） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1075-3） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1075-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981721 EUDAMED06974969982292 EUDAMED06974969981158 EUDAMED
- Basic UDI-DI
- B-06974969981721 EUDAMEDB-06974969982292 EUDAMEDB-06974969981158 EUDAMED
- EMDN Code
- W0102120103 HYALURONIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Hyaluronic Acid（HA）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoa… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969981721 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED e8dd1d45-199d-4b91-a17f-ce32eb1b7ebc 61 fields · synced Oct 6, 2026
- EUDAMED 4bb19b19-a68a-434e-973f-5aa4405fe968 61 fields · synced May 18, 2026
- EUDAMED 188e61be-7936-438f-b7aa-f7d1090614d8 61 fields · synced May 19, 2026