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A1 Acoustic Rhinometer Clinical Research

by GM Instruments Ltd United Kingdom(FDA 510(k) applicant) EUDAMED

Ref A1-CRModel A1 Acoustic Rhinometer EMDN Z12149009

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506048527GMA1ACOUFS Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
A1 Acoustic Rhinometer, A1-CR
Primary DI / UDI-DI
05060485270089
Basic UDI-DI
506048527GMA1ACOUFS
EMDN Code
Z12149009 Rhinometers
Device Class
Class IIa
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000020565
Authorised representative
Advena Limited MT-AR-000000234

Other devices from G.M. Instruments Ltd.

See all devices from G.M. Instruments Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b30dff57-1010-43a3-ba42-7f66bfe298ba 61 fields · synced 24 Oct 2026