β-hCG Quantitative Test Kit (Time-Resolved FIA)

Name: β-hCG Quantitative Test Kit (Time-Resolved FIA)
Brand: Zhejiang Orient Gene Biotech Co., Ltd
SKU: 06950996078252

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Identification

Model: FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG
EMDN: W0102160302
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.

6188440TD05

EU technical documentation assessment · valid

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

Valid from 2026-01-12 · Expiry 2031-01-01

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
β-hCG Quantitative Test Kit (Time-Resolved FIA)	06950996042581	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
β-hCG Quantitative Test Kit (Time-Resolved FIA)	06950996066884	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
β-hCG Quantitative Test Kit (Time-Resolved FIA)	06950996003933	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
β-hCG Quantitative Test Kit (Time-Resolved FIA)	06950996003926	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
β-hCG Quantitative Test Kit (Time-Resolved FIA)	06950996012454	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED