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Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Kylin Flow Diverter

UDI-DI 06972769421812Basic UDI-DI 697276942007AF5

Class III · MDR · Ton-Bridge Medical Tech. Co., Ltd.

Identification
Model
TQL-25-XX series, TQL-30-XX series, TQL-35-XX series, TQL-40-XX series, TQL-45-XX series, TQL-50-XX series, TQL-55-XX series, TQL-60-XX series, TQL-65-XX series
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

MDR.2292-2026/0087

EU technical documentation assessment · valid

Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)

Valid from 2026-10-08 · Expiry 2031-10-07

Scope not stated in certificate data.

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

Manufacturer

Ton-Bridge Medical Tech. Co., Ltd.

SRN CN-MF-000011793

CN · Zhuhai

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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Canonical device page: /device/kylin-flow-diverter-1812 · UDI page: /udi/06972769421812

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