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Adult mask

by Besmed Health Business Corp.

Ref OM-82415Model MD-38240

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4716770MD03800DU Basic UDI-DI 04716770824154UDI-DIDate22 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04716770824154 UDI-DI Date28 Dec 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Adult mask EUDAMED
adult face mask for chamber spacer GUDID
Generic Name
Respiratory oxygen therapy system
Device Name
MDI Spacer, Silicone mask, 220 ml, adult
Model / Reference
MD-38240, OM-82415
Primary DI / UDI-DI
04716770824154
Basic UDI-DI
4716770MD03800DU
Direct Marketing DI
04716770824154
FDA Product Code
BYG
EMDN Code
R03010302 Aerosol portable inhalers
GMDN Term
Respiratory oxygen therapy system
Device Class
Class I
Regulation Number
868.5580
EU market of registration
Slovenia
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
Casus Europe B.V. NL-AR-000037688

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Serial Number: No