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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Rad-97 Home Use

UDI-DI 00843997016605Basic UDI-DI 084399700000Z0T3A01V000EM

Class IIb · MDR · Masimo Corporation

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

28620149254-03

EU quality management system · unknown

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-12-18 · Expiry 2028-04-29

Scope not stated in certificate data.

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

Manufacturer

Masimo Corporation

SRN US-MF-000010641

US · Irvine

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rad-97-home-use-6605 · UDI page: /udi/00843997016605

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