No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

Fusion Bx

UDI-DI 00628055858010Basic UDI-DI 62805585801SF

Class IIa · MDR · Focal Healthcare Inc

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Identification

Model: 2.0
EMDN: Z110603
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

Focal Healthcare Inc

SRN CA-MF-000050812

CA · Toronto

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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/fusion-bx-8010 · UDI page: /udi/00628055858010

All devices from Focal Healthcare Inc

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