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Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

High-Sensitivity Cardiac Troponin I (hs-cTnI) Assay Kit (Chemiluminescent Immunoassay)

UDI-DI 06970522647851Basic UDI-DI B-06970522647851

Unknown class · IVDD (legacy) · Sichuan Orienter Biotechnology Co., Ltd.

Identification
Model
2×50 tests/box Calibrator: 0.5mL×6; Quality control: 1.0mL×2
Issuing agency
GS1
Device status
active
Sterile
No
Manufacturer

Sichuan Orienter Biotechnology Co., Ltd.

SRN CN-MF-000003026

CN · Chengdu

manufacturer

Authorised representative: Medunion S.L. (ES-AR-000019366)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/high-sensitivity-cardiac-troponin-i-hs-ctni-assay-kit-chemil-7851 · UDI page: /udi/06970522647851

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