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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Left Ventricular Assist System

UDI-DI 16974309711275Basic UDI-DI 697430971PICOPT

Class III · MDR · Shenzhen Core Medical Technology Co., Ltd.

Identification
Model
Corheart 6
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
Yes
Reusable surgical
No
Certificates

4940783TD01

EU technical documentation assessment · valid

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

Valid from 2026-07-29 · Expiry 2031-07-01

Scope not stated in certificate data.

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

4940783CE01

EU quality management system · valid

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

Valid from 2026-07-29 · Expiry 2031-07-01

Scope not stated in certificate data.

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

Manufacturer

Shenzhen Core Medical Technology Co., Ltd.

SRN CN-MF-000033296

CN · Shenzhen

manufacturer

Authorised representative: Wellkang Ltd (XI-AR-000001836)

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/left-ventricular-assist-system-1275 · UDI page: /udi/16974309711275

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