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Vitamin D Rapid Test Cassette

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref OVD-402HRef OVD-402

by Hangzhou Alltest Biotech.Co., Ltd.

Identity

Trade Name
Vitamin D Rapid Test Cassette EUDAMED
Device Name
Vitamin D Rapid Test Cassette EUDAMED
Model / Reference
OVD-402H EUDAMED
OVD-402 EUDAMED

Identifiers

Primary DI / UDI-DI
06936983100984 EUDAMED
06936983125826 EUDAMED
06936983188739 EUDAMED
06936983119207 EUDAMED
Basic UDI-DI
B-06936983100984 EUDAMED
B-06936983125826 EUDAMED
B-06936983188739 EUDAMED
B-06936983119207 EUDAMED
EMDN Code
W0102060309 25-HYDROXYVITAMIN D EUDAMED
W0103030901 COMBINED ABO TYPING + RHESUS D EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Class IVD General EUDAMED
Market of Registration
Ireland EUDAMED
Lithuania 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

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Manufacturer

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