Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

SEALSAC

UDI-DI 06971145487114Basic UDI-DI 697114548ECS-2D-ESZ6

Class III · MDR · Shanghai HeartCare Medical Technology Corporation Limited

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Identification

Model: ECS-1-1-HX-ES
EMDN: C010402020301
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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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sealsac-7114 · UDI page: /udi/06971145487114

All devices from Shanghai HeartCare Medical Technology Corporation Limited

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