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Tessys® TEFB2065B

by Joimax GmbH

Part of a family of 8 devices: see the family page

Ref TEFB2065B

Tessys® TEFB2065B is a Class I device made by Joimax GmbH, registered in EUDAMED on 29 Apr 2024 (Basic UDI-DI 42503371PALPENDG5) and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337102793), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371PALPENDG5 Basic UDI-DI 04250337102793UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337102793 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503371PALPENDG5 registered 29 Apr 2024 Active
  • FDA GUDID UDI-DI 04250337102793 listed 30 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337102793
  2. Registered EUDAMED 42503371PALPENDG5

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  • Withdrawn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
Clip for TESSYS® Endo-Flexprobe Handle EUDAMED
Tessys® GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Endo-Flexprobe
Model / Ref / Catalog
TEFB2065B
Primary DI / UDI-DI
04250337102793
Basic UDI-DI
42503371PALPENDG5
Direct marketing DI
04250337102793
FDA product code
GEG
EMDN code
L031102 Exploration probes, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under EXPLORATION PROBES, REUSABLE.

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)