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Duplex Aneroid CT Ambidex Cuff - Blue

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

Ref 0322ABModel Aneroid Sphygmomanometers EMDN Z1203020599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506048527GMACCSPHPU 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  • Withdrawn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 25 Oct 2026

Model / Reference
Aneroid Sphygmomanometers, 0322AB
Primary DI / UDI-DI
05060485271185
Basic UDI-DI
506048527GMACCSPHPU
EMDN Code
Z1203020599 Non-invasive blood pressure gauges - other
Device Class
Class I
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 05060485271185|506048527GMACCSPHPU 61 fields · synced 25 Oct 2026