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Rapid Iron Deficiency Ferritin Test

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Scan an inventory CSV

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

Identification

Model
GEFER-402a-H1, GEFER-402a-H2, GEFER-402a-H5, GEFER-402a-H10, GEFER-402a-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.

6188440TD13

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 19 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rapid-iron-deficiency-ferritin-test-4477 · UDI page: /udi/06950996064477

All devices from Zhejiang Orient Gene Biotech Co., Ltd