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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Equinoxe®

UDI-DI 10885862079299Basic UDI-DI 10885862100005NJ

Class III · MDR · Exactech, Inc.

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

MDR 761535

EU technical documentation assessment · valid

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

Valid from 2026-06-18 · Expiry 2031-06-17

Scope not stated in certificate data.

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

Manufacturer

Exactech, Inc.

SRN US-MF-000017730

US · Gainesville

manufacturer

Authorised representative: Blue Ortho SAS (FR-AR-000005249)

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/equinoxe-9299 · UDI page: /udi/10885862079299

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