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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Ultrasound Gels

UDI-DI 06941165062172Basic UDI-DI 694116500000002577

Class Is · MDR · Suzhou Leapmed Healthcare Corporation

Identification
Model
Sa40
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

EPT 0477.MDR.26/6235

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2026-07-20 · Expiry 2031-03-25

Scope not stated in certificate data.

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

Manufacturer

Suzhou Leapmed Healthcare Corporation

SRN CN-MF-000013964

CN · Suzhou City

manufacturer

Authorised representative: RIOMAVIX SOCIEDAD LIMITADA (ES-AR-000001202)

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/ultrasound-gels-2172 · UDI page: /udi/06941165062172

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