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TenderTip TT03-12-E54-N

by GBUK Group, Ltd.

Ref TT03-12-E54-N

TenderTip TT03-12-E54-N is a device classified as Class IIa in the EU and Class I in the US made by GBUK Group, Ltd., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-05056038303298) and listed in FDA GUDID since 2 Jun 2023 (UDI-DI 05056038303298), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05056038303298 Basic UDI-DI 05056038303298UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056038303298 UDI-DI Date2 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05056038303298 registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 05056038303298 listed 2 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05056038303298
  2. Registered EUDAMED B-05056038303298

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TenderTip
Generic name
Airway suction catheter
Model / Ref / Catalog
TT03-12-E54-N
Primary DI / UDI-DI
05056038303298
Basic UDI-DI
B-05056038303298
FDA product code
BSY
EMDN code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
GMDN term
Airway suction catheter
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.6810
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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: Airway suction catheter

Similar devices in this category

Other devices filed under RESPIRATORY SUCTION PROBES AND SYSTEMS.

Other devices from GBUK Group, Ltd.

See all devices from GBUK Group, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (20, all answered No)