Skip to content

Bi-Mask 2; 22 mm I.D.

by VBM Medizintechnik GmbH

Ref 35-65-222

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 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/MDR EUDAMED Number42501056-1.5.3-VR Basic UDI-DI 14250105629580UDI-DIDate9 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14250105629580 UDI-DI Date31 Jan 2023ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Bi-Mask 2; 22 mm I.D. EUDAMED
Bi-Mask GUDID
Generic Name
Anaesthesia face mask, reusable
Device Name
Face Masks - Bi-Mask
Model / Reference
35-65-222
Primary DI / UDI-DI
14250105629580
Basic UDI-DI
42501056-1.5.3-VR
Direct Marketing DI
04250105629583
FDA Product Code
BSJ
EMDN Code
R03010101 Anaesthetic face masks
GMDN Term
Anaesthesia face mask, reusable
Models / Variants
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 22 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005907

Related devices

Category: Anaesthesia face mask, single-use

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No