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25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52027111Model 50T/KitRef 52026116Model 25T/kit
Identity
- Trade Name
- 25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence) EUDAMED
- Device Name
- 25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 50T/Kit EUDAMED52027111 EUDAMED25T/kit EUDAMED52026116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FA0008Z8 EUDAMED06950334809470 EUDAMED
- Basic UDI-DI
- B-FA0008Z8 EUDAMEDB-06950334809470 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
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-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence) by Genrui Biotech Inc. — 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-FA0008Z8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e51bd834-787a-45d9-a9a1-4f9490cbed33 61 fields · synced Jul 27, 2026
- EUDAMED 90fa57f0-6559-4e3f-90ee-74db78075d73 61 fields · synced May 18, 2026