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Tonbridge Gekko Detachable Coil System

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 06972769420488Basic UDI-DI 697276942002AEN

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

Identification

Model
AEC-XX-XX-S series, AEC-XX-XX-H series
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

MDR.2292-2026/0086

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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Showing 12 of 88 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/tonbridge-gekko-detachable-coil-system-0488 · UDI page: /udi/06972769420488

All devices from Ton-Bridge Medical Tech. Co., Ltd.