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Teleflex IPN928806

by Teleflex Incorporated

Ref STB38

Teleflex IPN928806 (STB38) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 08019020000000000000275KZ), cleared under FDA 510(k) K222085 on 31 Oct 2022 and listed in FDA GUDID since 13 May 2025 (UDI-DI 14026704921765), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222085

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000275KZ Basic UDI-DI 14026704921765UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704921765 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222085 Date31 Oct 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000275KZ registered 6 Jul 2026 Active
  • FDA 510(k) K222085 decided 31 Oct 2022 Active
  • FDA GUDID UDI-DI 14026704921765 listed 13 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222085
  2. Listed FDA GUDID 14026704921765
  3. Registered EUDAMED 08019020000000000000275KZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Standard Precision Bougie™ Device EUDAMED
Teleflex GUDID
Generic name
Oesophageal bougie, single-use
Model / Ref / Catalog
STB38, IPN928806
Primary DI / UDI-DI
14026704921765
Basic UDI-DI
08019020000000000000275KZ
510(k) Number
FDA product code
KNT
EMDN code
G010101 Oesophageal bougies
GMDN term
Oesophageal bougie, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5980
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
STB38
GUDID
IPN928806
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Oesophageal bougie, single-use

Cleared under the same submission (K222085)

Similar devices in this category

Other devices filed under OESOPHAGEAL BOUGIES.

Other devices from Teleflex Incorporated

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    Class II

See all devices from Teleflex Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)