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Venturi Mask, 6 diluters, adult

by Besmed Health Business Corp.

Ref VM-98012

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-VM-98012A7 Basic UDI-DI D-VM-98012A7UDI-DIDate5 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-VM-98012A7 UDI-DI Date29 Dec 2017ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Venturi Mask, 6 diluters, adult EUDAMED
Venturi Mask Adult W/6 Diluters, W/7FT Tubing, 6 Inch Corrugate Tube GUDID
Generic Name
Venturi oxygen face mask
Device Name
Venturi Mask, 6 diluters(24%~50%), Adult
Model / Reference
VM-98012
Primary DI / UDI-DI
D-VM-98012A7 EUDAMED
04716770980126 GUDID
Basic UDI-DI
B-VM-98012A7
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-VM-98012A7
GUDID
04716770980126
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

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

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Properties

  • 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