Identity
- Trade Name
- 25-OH-VD Assay Kit CLIA EUDAMED
- Device Name
- 25-OH-VD Assay Kit CLIA EUDAMED
- Model / Reference
- SUPM046072 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521000983 EUDAMED
- Basic UDI-DI
- B-06974521000983 EUDAMED
- EMDN Code
- W0102070206 VITAMIN D (CHOLECALCIFEROL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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-OH-VD Assay Kit CLIA by Shenzhen Superbio Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06974521000983 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 70eff9d6-b5ea-4c73-bb1a-6606a2f87a80 61 fields · synced Jun 18, 2026