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Adjustable Venturi Mask, adult

by Besmed Health Business Corp. Taiwan EUDAMEDGUDID

Ref VM-98110 Product code BYFEMDN R03010202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-VM-98110A8 Basic UDI-DIDate5 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-VM-98110A8 UDI-DIDate29 Dec 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
VENTURI MASK ADULT W/AJUSTABLE DULITER,7FT TUBING/CORRUGATE TUBE,OD:22mm
Generic Name
Venturi oxygen face mask
Device Name
Adjustable Venturi Mask, adult
Model / Reference
VM-98110
Primary DI / UDI-DI
D-VM-98110A8 EUDAMED
04716770981109 GUDID
Basic UDI-DI
B-VM-98110A8
FDA Product Code
BYF
EMDN Code
R03010202 Venturi masks
GMDN Term
Venturi oxygen face mask
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5600
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-VM-98110A8
GUDID
04716770981109
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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

Sources (2)

  • EUDAMED 7be82f56-c375-4f36-b9fa-cd97667f63c6 61 fields · synced 22 Oct 2026
  • FDA UDI c04d5980-fe32-4541-a260-4a61133ebbe7 33 fields · synced 30 May 2026