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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

28mm Mitral Heart Valve

UDI-DI 00850035587065Basic UDI-DI 0850035587631000-2879

Class III · MDR · HighLife

Identification
Model
631000-28
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2292597TD01

EU technical documentation assessment · unknown

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

Valid from 2026-07-31 · Expiry 2031-01-01

Scope not stated in certificate data.

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

2292597CE01

EU quality management system · unknown

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

Valid from 2026-07-31 · Expiry 2031-01-01

Scope not stated in certificate data.

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

Manufacturer

HighLife

SRN FR-MF-000015887

FR · Paris

manufacturer

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/28mm-mitral-heart-valve-7065 · UDI page: /udi/00850035587065

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