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SEALSAC

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

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Class III · MDR · Shanghai HeartCare Medical Technology Corporation Limited

Identification

Model
ECS-1-2-3D-ES
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

MDR.2292-2026-0081

EU technical documentation assessment · valid

Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)

Valid from 2026-10-09 · Expiry 2031-09-29

Scope not stated in certificate data.

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

Manufacturer

Shanghai HeartCare Medical Technology Corporation Limited

SRN CN-MF-000001941

CN · Shanghai

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

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Showing 12 of 17 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sealsac-7428 · UDI page: /udi/06971145487428

All devices from Shanghai HeartCare Medical Technology Corporation Limited