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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

PSA Quantitative Test Kit (Time-Resolved FIA)

UDI-DI 06950996061162Basic UDI-DI 69509960FEPSA-402a-DRZB

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

Identification
Model
10 tests/kit
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

6188440TD02

EU technical documentation assessment · valid

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

Valid from 2025-06-19 · Expiry 2030-06-01

Scope not stated in certificate data.

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

6188440CE01

EU quality management system · unknown

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

Valid from 2026-07-01 · Expiry 2030-04-01

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/psa-quantitative-test-kit-time-resolved-fia-1162 · UDI page: /udi/06950996061162

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