HbA1c Quantitative Test Kit (Time-Resolved FIA)

Name: HbA1c Quantitative Test Kit (Time-Resolved FIA)
Brand: Zhejiang Orient Gene Biotech Co., Ltd
SKU: 06950996077798

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Identification

Model: FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-402a-DRHG
EMDN: W0102160102
Issuing agency: GS1
Device status: active
Sterile: No

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.

6188440TD10

EU technical documentation assessment · valid

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

Valid from 2026-05-01 · Expiry 2031-05-01

Scope not stated in certificate data.

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

SRN CN-MF-000017965

CN · Huzhou,Zhejiang

manufacturer

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

Name	UDI-DI	Certificate
HbA1c Quantitative Test Kit (Time-Resolved FIA)	06950996007047	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
HbA1c Quantitative Test Kit (Time-Resolved FIA)	06950996003964	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
HbA1c Quantitative Test Kit (Time-Resolved FIA)	06950996002356	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
HbA1c Quantitative Test Kit (Time-Resolved FIA)	06950996003940	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
HbA1c Quantitative Test Kit (Time-Resolved FIA)	06950996058018	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED