No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

Breathe Monster -Oral Strip (Sleep Strip)

UDI-DI 00850081122012Basic UDI-DI 0850081122BMOX3

Class I · MDR · Nekteck, Inc.

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Identification

Model: NK-SH02
EMDN: V9099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

SRN US-MF-000056880

US · Irvine CA

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

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/breathe-monster-oral-strip-sleep-strip-2012 · UDI page: /udi/00850081122012

All devices from Nekteck, Inc.

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