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Vitamin D Rapid Test Cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref OVD-402HRef OVD-402
Identity
- Trade Name
- Vitamin D Rapid Test Cassette EUDAMED
- Device Name
- Vitamin D Rapid Test Cassette EUDAMED
- Model / Reference
- OVD-402H EUDAMEDOVD-402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983100984 EUDAMED06936983125826 EUDAMED06936983188739 EUDAMED06936983119207 EUDAMED
- Basic UDI-DI
- B-06936983100984 EUDAMEDB-06936983125826 EUDAMEDB-06936983188739 EUDAMEDB-06936983119207 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMEDW0103030901 COMBINED ABO TYPING + RHESUS D EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDLithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Vitamin D Rapid Test Cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — 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-06936983100984 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 5d928f4b-a147-4638-a7e8-3d24b2e9ddac 61 fields · synced Jul 20, 2026
- EUDAMED 91bbbbcd-9763-4be9-9acc-bf613e795750 61 fields · synced May 17, 2026
- EUDAMED ac7430e9-4507-47b4-bd4f-8a11f0413371 61 fields · synced May 18, 2026
- EUDAMED 8f7c8c75-e7ee-46df-adbf-4a9101ee1467 61 fields · synced May 19, 2026