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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Ultraflex™

UDI-DI 08714729646112Basic UDI-DI 01915060000000000000122MF

Class IIb · MDR · Boston Scientific Corporation

Identification
Model
—
EMDN
P0401
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

3827895TD02

EU technical documentation assessment · valid

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

Valid from 2023-03-22 · Expiry 2028-03-22

Scope not stated in certificate data.

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

Manufacturer

Boston Scientific Corporation

SRN US-MF-000004702

US · Marlborough

manufacturer

Authorised representative: Boston Scientific Limited (IE-AR-000003840)

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Canonical device page: /device/ultraflextm-08714729646112 · UDI page: /udi/08714729646112

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