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

No Certificate FoundLegacy device

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 06970522647851Basic UDI-DI B-06970522647851

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

Identification

Model: 2×50 tests/box Calibrator: 0.5mL×6; Quality control: 1.0mL×2
EMDN: W01021306
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.

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

All devices from Sichuan Orienter Biotechnology Co., Ltd.