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Henry Schein 5701836

by Henry Schein, Inc.

Ref 5701836Model TF-123

Henry Schein 5701836 is a device classified as Class IIa in the EU and Class I in the US made by Henry Schein, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-10304040127848) and listed in FDA GUDID since 30 Sep 2020 (UDI-DI 10304040127848), 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-10304040127848 Basic UDI-DI 10304040127848UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10304040127848 UDI-DI Date30 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10304040127848 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 10304040127848 listed 30 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10304040127848
  2. Registered EUDAMED B-10304040127848

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  • Withdrawn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
Henry Schein
Generic name
Manual endodontic file/rasp, reusable
Device name
Rotary NiTi file U Coro CX orange 19mm
Model / Ref / Catalog
5701836, TF-123
Primary DI / UDI-DI
10304040127848
Basic UDI-DI
B-10304040127848
FDA product code
EKS
EMDN code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10304040127848: EUDAMED states Yes, FDA GUDID states No.

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: Manual endodontic file/rasp, reusable

Similar devices in this category

Other devices filed under ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE.

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)