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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

HiRise

UDI-DI 00860004550037Basic UDI-DI 8631520003CBCTDevicesCL

Class IIb · MDR · CurveBeam LLC

Identification
Model
1040
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

28620146078-02

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2025-02-10 · Expiry 2027-06-20

Scope not stated in certificate data.

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

Manufacturer

CurveBeam LLC

SRN US-MF-000004033

US · Hatfield

manufacturer

Authorised representative: ea-services (FR-AR-000003449)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hirise-0037 · UDI page: /udi/00860004550037

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