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Rapid Vitamin D Self-Test

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

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Class C · IVDR · Zhejiang Orient Gene Biotech Co., Ltd

Identification

Model
GIVD-402b-H1, GIVD-402b-H2, GIVD-402b-H5, GIVD-402b-H10, GIVD-402b-H20
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

6188440CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-09-01 · Expiry 2030-04-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

6188440TD12

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-09-01 · Expiry 2031-09-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

SRN CN-MF-000017965

CN · Huzhou,Zhejiang

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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Showing 12 of 17 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rapid-vitamin-d-self-test-8875 · UDI page: /udi/06950996028875

All devices from Zhejiang Orient Gene Biotech Co., Ltd