Unknown / Not in EUDAMED

Snapshot 2026-10-17 · Link to EUDAMED

Urinary Catheters for Single Use (Foley)

UDI-DI 06948097050994Basic 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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Urinary Catheters for Single Use (Foley) 06948097054374
Urinary Catheters for Single Use (Foley) 06948097054503
Urinary Catheters for Single Use (Foley) 06948097050383
Urinary Catheters for Single Use (Foley) 06948097054053
Urinary Catheters for Single Use (Foley) 06948097054480
Urinary Catheters for Single Use (Foley) 06948097054275
Urinary Catheters for Single Use (Foley) 06948097053919
Urinary Catheters for Single Use (Foley) 06948097053872
Urinary Catheters for Single Use (Foley) 06948097050680

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-0994 · UDI page: /udi/06948097050994

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

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