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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Diagnostic Ultrasound System

UDI-DI 06975329590010Basic UDI-DI 697532959A01100014P

Class IIa · MDR · Shenzhen Krinwave Technology Co., Ltd.

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

FI25/1008014

EU quality management system · unknown

Notified body: SGS FIMKO OY (0598)

Valid from 2025-06-30 · Expiry 2030-06-02

Scope not stated in certificate data.

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

Manufacturer

Shenzhen Krinwave Technology Co., Ltd.

SRN CN-MF-000032042

CN · Shenzhen

manufacturer

Authorised representative: Umedwings Netherlands B.V. (NL-AR-000000444)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/diagnostic-ultrasound-system-0010 · UDI page: /udi/06975329590010

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