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Breathe Monster -Nasal Strip

by Nekteck, Inc. EUDAMED

Active European Union

Ref NK-SH01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850081122BMNWZ Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Breathe Monster -Nasal Strip
Model / Reference
NK-SH01
Primary DI / UDI-DI
00850081122005
Basic UDI-DI
0850081122BMNWZ
EMDN Code
Q030199 Nasopharyngeal devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000056880
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Nekteck, Inc.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No