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Anesthesia mask

by Henan Tuoren Medical Device Co., Ltd China EUDAMED

Ref AMH006Model Inflatable-Normal type,Inflatable-Soft shell type,Inflatable-Handheld type,Inflatable- Ergo mask

EMDN R03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number693811937358K9 Basic UDI-DIDate9 Apr 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
Inflatable-Normal type,Inflatable-Soft shell type,Inflatable-Handheld type,Inflatable- Ergo mask, AMH006
Primary DI / UDI-DI
16941617113824, 26941617113821, 06941617113827
Basic UDI-DI
693811937358K9
EMDN Code
R03010101 Anaesthetic face masks
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000013924
Authorised representative
MedNet EC-REP C III GmbH DE-AR-000011196

Other devices from Henan Tuoren Medical Device Co., Ltd.

See all devices from Henan Tuoren Medical Device Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 0b931328-fc8f-4478-b0fb-60878d220e8d 61 fields · synced 22 Oct 2026
  • EUDAMED 26941617113821|693811937358K9 61 fields · synced 18 May 2026
  • EUDAMED 06941617113827|693811937358K9 61 fields · synced 19 May 2026