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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

MeCross NC PTCA Balloon Dilatation Catheter

UDI-DI 06973710640498Basic UDI-DI 697371064MC02H7

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

Identification
Model
MC-02-2008,MC-02-2010,MC-02-2012,MC-02-2015,MC-02-2018,MC-02-2208,MC-02-2210,MC-02-2212,MC-02-2215,MC-02-2218,MC-02-2508,MC-02-2510,MC-02-2512,MC-02-2515,MC-02-2518,MC-02-2708,MC-02-2710,MC-02-2712,MC-02-2715,etc
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 786406

EU technical documentation assessment · valid

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

Valid from 2026-09-17 · Expiry 2031-09-16

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-nc-ptca-balloon-dilatation-catheter-0498 · UDI page: /udi/06973710640498

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