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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Wedge NC

UDI-DI 06958481453331Basic UDI-DI 695848140005LZ

Class III · MDR · BrosMed Medical Co., Ltd

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

MDR.2292-2026/0057

EU technical documentation assessment · valid

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

Valid from 2026-08-05 · Expiry 2031-08-04

Scope not stated in certificate data.

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

Manufacturer

BrosMed Medical Co., Ltd

SRN CN-MF-000007501

CN · Dongguan, Guangdong

manufacturer

Authorised representative: Brosmed Medical B.V. (NL-AR-000002616)

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Canonical device page: /device/wedge-nc-scoring-balloon-dilatation-catheter-3331 · UDI page: /udi/06958481453331

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