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Anesthesia mask

by Henan Tuoren Medical Device Co., Ltd EUDAMED

Active European Union

Ref IAM000Model Inflatable-Normal type，Inflatable-Soft shell type，Inflatable-Handheld type，Inflatable- Ergo mask

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number693811937358K9 Basic UDI-DIDate9 Apr 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  • Withdrawn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

Device Name
Anesthesia mask
Model / Reference
Inflatable-Normal type，Inflatable-Soft shell type，Inflatable-Handheld type，Inflatable- Ergo mask, IAM000
Primary DI / UDI-DI
26941617113692, 16941617113695, 06941617113698
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

Related devices

Category: Anaesthesia face mask, single-use

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

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

Properties

  • 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