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TRACOE cuff pressure monitor sensitive Tubing: Length: 100 cm - female Luer Lock, male Luer

by VBM Medizintechnik GmbH

Ref 721

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number42501056-1.1.1-UP Basic UDI-DI 04035324020201UDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04035324020201 UDI-DI Date30 Jun 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
TRACOE cuff pressure monitor sensitive Tubing: Length: 100 cm; female Luer Lock, male Luer EUDAMED
TRACOE® sensitive GUDID
Generic Name
Endotracheal tube cuff inflator
Device Name
Cuff Pressure Gauges - Cuff Manometer
Model / Reference
721 EUDAMED
REF 721 GUDID
Primary DI / UDI-DI
04035324020201
Basic UDI-DI
42501056-1.1.1-UP
Direct Marketing DI
04035324020201
510(k) Number
FDA Product Code
BSK
EMDN Code
R01038001 Endotracheal tube cuffs inflation systems
GMDN Term
Endotracheal tube cuff inflator
Models / Variants
female Luer Lock, male Luer
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.5750
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
721
GUDID
REF 721
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005907

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No