Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Urinary Catheters for Single Use (Foley)

UDI-DI 06948097053797Basic UDI-DI 6948097001DNGGN

Class IIb · MDR · Haiyan Kangyuan Medical Instrument Co.,Ltd.

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Identification

Model: Two-Way, Three-Way; Normal Balloon, Integral Flat Balloon; Nelaton Tip, Tiemann Tip
EMDN: U020299
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

6122159CE01

EU quality management system · unknown

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

Valid from 2025-04-10 · Expiry 2028-02-01

Scope not stated in certificate data.

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

Manufacturer

Haiyan Kangyuan Medical Instrument Co.,Ltd.

SRN CN-MF-000001532

CN · Zhejiang

manufacturer

Authorised representative: Eunitor GmbH (DE-AR-000005081)

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Showing 12 of 193 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/urinary-catheters-for-single-use-foley-3797 · UDI page: /udi/06948097053797

All devices from Haiyan Kangyuan Medical Instrument Co.,Ltd.

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