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25-Hydroxyvitamin D Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3010688Model 1×100 Tests/kitRef 3013918Model 2×50 Tests/kitRef 3010668Model 1×50 Tests/kit
Identity
- Trade Name
- 25-Hydroxyvitamin D Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- 25-Hydroxyvitamin D Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×100 Tests/kit EUDAMED3010688 EUDAMED2×50 Tests/kit EUDAMED3013918 EUDAMED1×50 Tests/kit EUDAMED3010668 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518491 EUDAMED06942202223846 EUDAMED06925794518484 EUDAMED
- Basic UDI-DI
- B-06925794518491 EUDAMEDB-06942202223846 EUDAMEDB-06925794518484 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06925794518491 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2111a186-002c-4bfb-a5c6-40197b80719b 61 fields · synced Jul 27, 2026
- EUDAMED 34838bee-b35b-49ca-918c-5e3753ccb4f8 61 fields · synced May 16, 2026
- EUDAMED e9c4ce1a-f939-43a3-8719-8c96c062617a 61 fields · synced May 18, 2026