Skip to content

Henry Schein

by Henry Schein Inc. 104 variants

Part of a family of 16 devices: see the family page

Ref 5722638Model TF-231 (HS)

Henry Schein (5722638) is a Class I device made by Henry Schein, Inc., registered in EUDAMED on 10 Mar 2026 (Basic UDI-DI 03040423101BH) and listed in FDA GUDID since 31 Jan 2020 (UDI-DI 10304040121051), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03040423101BH Basic UDI-DI 10304040121051UDI-DIDate10 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040121051 UDI-DI Date31 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03040423101BH registered 10 Mar 2026 Active
  • FDA GUDID UDI-DI 10304040121051 listed 31 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10304040121051
  2. Registered EUDAMED 03040423101BH

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  • Withdrawn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

Generic name
Dental matrix band, single-use
Device name
Matrix bands
Model / Ref / Catalog
TF-231 (HS), 5722638
Primary DI / UDI-DI
10304040121051
Basic UDI-DI
03040423101BH
Unit of use DI
00304040121054
FDA product code
JEP
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental matrix band, single-use
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000021683
Authorised representative
Henry Schein Services GmbH DE-AR-000008001

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)