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X-Changer 11 Fr; Length: 80 cm; O2-15 mm O.D.; O2

by VBM Medizintechnik GmbH

Ref 33-42-800-1

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 Number42501056-1.6.5-V01-MT Basic UDI-DI 04250105629729UDI-DIDate19 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105629729 UDI-DI Date14 Aug 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  • Withdrawn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
X-Changer 11 Fr; Length: 80 cm; O2-15 mm O.D.; O2 EUDAMED
X-Changer GUDID
Generic Name
Endotracheal tube introducer, single-use
Device Name
Intubation Aids - X-Changer
Model / Reference
33-42-800-1
Primary DI / UDI-DI
04250105629729
Basic UDI-DI
42501056-1.6.5-V01-MT
FDA Product Code
BSR
EMDN Code
R01038099 Endotracheal tubes - accessories not included in other classes
GMDN Term
Endotracheal tube introducer, single-use
Models / Variants
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5790
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Length — 80 Centimeter
Outer Diameter — 15 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005907

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Properties

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

Other properties (17)

  • 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