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Mandibular tracker

by ModJaw 4 variants

Ref TALLY

Mandibular tracker (TALLY) is a jaw physiology evaluation system (EU MDR Class I; FDA Class I; FDA product code NFS, Device, Jaw Tracking, For Monitoring Jaw Positions) made by Modjaw, registered in EUDAMED on 22 Apr 2024 (Basic UDI-DI 3770022347KITREU5V) and listed in FDA GUDID since 23 Feb 2022 (UDI-DI 03770022347144), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770022347KITREU5V Basic UDI-DI 03770022347144UDI-DIDate22 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number03770022347144 UDI-DI Date23 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3770022347KITREU5V registered 22 Apr 2024 Active
  • FDA GUDID UDI-DI 03770022347144 listed 23 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03770022347144
  2. Registered EUDAMED 3770022347KITREU5V

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  • Withdrawn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
Pen Tracker
Generic name
Jaw physiology evaluation system
Device name
Mandibular tracker
Model / Ref / Catalog
TALLY, Pen Tracker
Description
The pen is used in order to collect positioning of reference points in space. The pen is used to calibrate the precision of the device.
Primary DI / UDI-DI
03770022347144
Basic UDI-DI
3770022347KITREU5V
Direct marketing DI
03770022347144
FDA product code
NFS
EMDN code
Q0199 Odontology devices - other
GMDN term
Jaw physiology evaluation system
Device class
Class I
Regulation number
872.2060
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
FR-MF-000009804

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Modjaw

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)