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Anesthesia Mask

by Ningbo Luke Medical Devices Co., LTD China EUDAMED

Ref AMPA0SModel Sterile PVC Anesthesia Mask

EMDN R03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697024089AMPSK2 Basic UDI-DIDate15 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Anesthesia Mask
Model / Reference
Sterile PVC Anesthesia Mask, AMPA0S
Primary DI / UDI-DI
06970240896289
Basic UDI-DI
697024089AMPSK2
Direct Marketing DI
06970240896289
EMDN Code
R03010101 Anaesthetic face masks
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000011732
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 8c4740f9-1012-4eb5-b939-7c26ac22b50a 61 fields · synced 22 Oct 2026