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25-hydroxyvitamin D Assay Kit (Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 tests/kitRef 10 tests/kitRef 100 tests/kit
Identity
- Trade Name
- 25-hydroxyvitamin D Assay Kit (Immunochromatographic Assay) EUDAMED
- Device Name
- 25-hydroxyvitamin D Assay Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMED10 tests/kit EUDAMED100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986812640 EUDAMED06974986812633 EUDAMED06974986812664 EUDAMED
- Basic UDI-DI
- B-06974986812640 EUDAMEDB-06974986812633 EUDAMEDB-06974986812664 EUDAMED
- EMDN Code
- W0102070299 VITAMIN TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
25-hydroxyvitamin D Assay Kit (Immunochromatographic Assay) by Wuhan Life Origin Biotech Joint Stock 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-06974986812640 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 7321f947-6b35-4f61-91b9-6f042bf44f80 61 fields · synced Oct 6, 2026
- EUDAMED 04782ed8-bae6-427f-80f7-27d47bc55c76 61 fields · synced May 17, 2026
- EUDAMED 38b4f764-5a21-40bb-a6e2-457c2719de8d 61 fields · synced May 18, 2026