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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

AlwideTM Plus Balloon Catheter

UDI-DI 06971493531897Basic UDI-DI 697149353XT0007CE25

Class III · MDR · Shanghai MicroPort CardioFlow Medtech Co., Ltd.

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

6126688TD02

EU technical documentation assessment · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-10-22 · Expiry 2030-08-01

Scope not stated in certificate data.

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

6126688CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-10-15 · Expiry 2029-04-01

Scope not stated in certificate data.

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

Manufacturer

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

SRN CN-MF-000002327

CN · Shanghai

manufacturer

Authorised representative: MicroPort Medical B.V. (NL-AR-000000166)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/alwidetm-plus-balloon-catheter-1897 · UDI page: /udi/06971493531897

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