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01-20-000

by VBM Medizintechnik GmbH

Ref 01-20-000

01-20-000 is a device classified as Class IIa in the EU and Class I in the US made by VBM Medizintechnik GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI 42501056-3.1.1-VH) and listed in FDA GUDID since 29 May 2019 (UDI-DI 14250105628187), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42501056-3.1.1-VH Basic UDI-DI 14250105628187UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14250105628187 UDI-DI Date29 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42501056-3.1.1-VH registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI 14250105628187 listed 29 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14250105628187
  2. Registered EUDAMED 42501056-3.1.1-VH

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  • Withdrawn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
Tourniquet Touch TT20
Generic name
Surgical pneumatic tourniquet system
Device name
Tourniquet Devices - TQ-Touch
Model / reference
01-20-000
Primary DI / UDI-DI
14250105628187
Basic UDI-DI
42501056-3.1.1-VH
Direct marketing DI
04250105628180
FDA product code
KCY
EMDN code
Z12139006 Pneumatic tourniquets
GMDN term
Surgical pneumatic tourniquet system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.5910
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical pneumatic tourniquet system

Similar devices in this category

Other devices filed under PNEUMATIC TOURNIQUETS.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)