Certificate valid

Snapshot 2026-10-19 · Link to EUDAMED

Wedge NC

UDI-DI 06958481453522Basic UDI-DI 695848140005LZ

Class III · MDR · BrosMed Medical Co., Ltd

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Identification

Model: —
EMDN: C010401020101
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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Showing 12 of 44 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/wedge-nc-scoring-balloon-dilatation-catheter-3522 · UDI page: /udi/06958481453522

All devices from BrosMed Medical Co., Ltd

Scan an inventory CSV