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Temrex Bitewing Loops 2400, 2410

by Temrex Corp.

Ref 2400, 2410

Temrex Bitewing Loops 2400, 2410 is a Class I device made by Temrex Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00850015110542) and listed in FDA GUDID since 22 Oct 2020 (UDI-DI 00850015110542), active as of 7 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850015110542 Basic UDI-DI 00850015110542UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850015110542 UDI-DI Date22 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850015110542 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00850015110542 listed 22 Oct 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850015110542
  2. Registered EUDAMED B-00850015110542

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  • Withdrawn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
Temrex EUDAMED
Temrex Bitewing Loops GUDID
Generic name
Dental x-ray film holder, reusable
Device name
Bite Wing Loops
Model / reference
2400, 2410
Primary DI / UDI-DI
00850015110542
Basic UDI-DI
B-00850015110542
FDA product code
EGZ
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Dental x-ray film holder, reusable
Device class
Class I
Regulation number
872.1905
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental x-ray film holder, reusable

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Premarket exempt
Other properties (21, all answered No)