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Air cushion mask

by Hsiner Co., Ltd. 71 variants

Ref 20353

Air cushion mask (20353) is a Class IIa device made by Hsiner Co., Ltd., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-04712688050746), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04712688050746 Basic UDI-DI Date4 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Air cushion mask
Model / reference
20353
Primary DI / UDI-DI
04712688050746, 04711064685497
Basic UDI-DI
B-04712688050746, B-04711064685497
EMDN code
R03010101 Anaesthetic face masks
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000007258
Authorised representative
mdi Europa GmbH DE-AR-000006218

Similar devices in this category

Other devices filed under ANAESTHETIC FACE MASKS.

Other devices from Hsiner Co., Ltd.

See all devices from Hsiner Co., Ltd. →

Properties

Other properties (12, all answered No)