Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

MeCross CTO PTCA Balloon Dilatation Catheter

UDI-DI 06973710640016Basic UDI-DI 697371064MC01H5

Class III · MDR · Shenzhen Medoo Medical Tech. Co., Ltd

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Identification

Model: MC-01-1010, MC-01-1015, MC-01-1020, MC-01-1030, MC-01-1210, MC-01-1215, MC-01-1220, MC-01-1230,MC-01-1510,MC-01-1515,MC-01-1520,MC-01-1530,etc
EMDN: C010401020101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 786405

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-03-19 · Expiry 2030-03-18

Scope not stated in certificate data.

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

Manufacturer

Shenzhen Medoo Medical Tech. Co., Ltd

SRN CN-MF-000011452

CN · Shenzhen, Guangdong

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/mecross-cto-ptca-balloon-dilatation-catheter-0016 · UDI page: /udi/06973710640016

All devices from Shenzhen Medoo Medical Tech. Co., Ltd

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