← Back to catalogue
25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref PO-0009-01Model PF10 25tests/kit
Identity
- Trade Name
- 25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography) EUDAMED
- Device Name
- 25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- PF10 25tests/kit EUDAMEDPO-0009-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306453 EUDAMED
- Basic UDI-DI
- B-06941377306453 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 Kit (Fluorescence Immunochromatography) by Shenzhen Dymind Biotechnology 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-06941377306453 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 10bbfd64-d0f6-4b6e-b538-854a00cadb77 61 fields · synced Jul 20, 2026