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Quicktrach II Quicktrach: 15 mm O.D ; Canula: 4.0 mm I.D. ; Tubing: 15 mm I.D. / 22 mm I.D.

by VBM Medizintechnik GmbH

Ref 30-10-004-1

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42501056-1.3.8-VS Basic UDI-DI 04250105629972UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105629972 UDI-DI Date8 Nov 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
Quicktrach II Quicktrach: 15 mm O.D ; Canula: 4.0 mm I.D. ; Tubing: 15 mm I.D. / 22 mm I.D. EUDAMED
Quicktrach II GUDID
Generic Name
Cricothyrotomy kit, single-use
Device Name
Cricothyrotomy - Quicktrach II
Model / Reference
30-10-004-1
Primary DI / UDI-DI
04250105629972
Basic UDI-DI
42501056-1.3.8-VS
510(k) Number
FDA Product Code
BTO
EMDN Code
R010699 Percutaneous tracheostomy kits - other
GMDN Term
Cricothyrotomy kit, single-use
Models / Variants
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 4 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005907

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Manufacturing Date: No