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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

InSpace™ system

UDI-DI 17290013396034Basic UDI-DI 7290013396034XC

Class III · MDR · Ortho-Space Ltd

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

3903006TD01

EU technical documentation assessment · valid

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

Valid from 2024-01-08 · Expiry 2028-02-01

Scope not stated in certificate data.

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

3903006CE01

EU quality management system · valid

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

Valid from 2024-01-08 · Expiry 2028-02-01

Scope not stated in certificate data.

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

Manufacturer

Ortho-Space Ltd

SRN IL-MF-000018637

IL · Caesarea

manufacturer

Authorised representative: CEpartner4U (NL-AR-000000111)

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/inspacetm-system-6034 · UDI page: /udi/17290013396034

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