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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

HDR 1000 Plus

UDI-DI 00866562000212Basic UDI-DI 08665620002WELLCHAMBERAQ

Class Im · MDR · Standard Imaging, Inc.

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

28620136130-01

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-02-22 · Expiry 2027-10-18

Scope not stated in certificate data.

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

Manufacturer

Standard Imaging, Inc.

SRN US-MF-000009855

US · Middleton

manufacturer

Authorised representative: Hoff & Lowendahl AB (SE-AR-000001888)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hdr-1000-plus-0212 · UDI page: /udi/00866562000212

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