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Arie Full Face Vented Mask, Medium

by Sleepnet Corporation EUDAMEDGUDID

Active European Union

Ref 50805

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08147470219NA Basic UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00814747024720 UDI-DIDate4 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
CPAP/BPAP face mask, reusable
Device Name
Full Face Mask
Model / Reference
50805
Primary DI / UDI-DI
00814747024720
Basic UDI-DI
08147470219NA
FDA Product Code
BZD
EMDN Code
R0301010201 Cpap masks
GMDN Term
CPAP/BPAP face mask, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5905
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000010620
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

From the manufacturer

Manufacturer's product page: Arie® Full Face Mask Light as air, strong in care

Other devices from Sleepnet Corporation

See all devices from Sleepnet Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No