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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Fast Warm – NX

UDI-DI 00810195241603Basic UDI-DI 08101952490196HG

Class III · MDR · Irvine Scientific, LLC.

Identification
Model
90196
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 835884

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-25 · Expiry 2031-08-24

Scope not stated in certificate data.

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

Manufacturer

Irvine Scientific, LLC.

SRN US-MF-000007514

US · Santa Ana

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fast-warm-nx-1603 · UDI page: /udi/00810195241603

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