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Tmjoint 1.0

by Bts SpA

Ref TMJModel TMJOINT

Tmjoint 1.0 (BTSEMB1BM) is a device classified as Class I in the EU and Class II in the US made by Bts SpA, registered in EUDAMED on 20 May 2026 (Basic UDI-DI ++B179TEETHAN2W) and listed in FDA GUDID since 12 Feb 2017 (UDI-DI B179TMJ), 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 Number++B179TEETHAN2W Basic UDI-DI B179TMJUDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB179TMJ UDI-DI Date12 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B179TEETHAN2W registered 20 May 2026 Active
  • FDA GUDID UDI-DI B179TMJ listed 12 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B179TMJ
  2. Registered EUDAMED ++B179TEETHAN2W

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  • Withdrawn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
Teethan EUDAMED
Tmjoint GUDID
Generic name
Electromyograph
Model / Ref / Catalog
TMJOINT EUDAMED
TMJ EUDAMED
1.0 GUDID
BTSEMB1BM GUDID
Primary DI / UDI-DI
B179TMJ
Basic UDI-DI
++B179TEETHAN2W
FDA product code
HCC
EMDN code
Z12062401 Electromyographic biofeedback systems
GMDN term
Electromyograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TMJOINT
TMJ
GUDID
1.0
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electromyograph

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS.

Other devices from Bts SpA

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    Class II

  • Smart Dx EVO2

    Class II

  • P6000

    Class I

  • Smart Dx EVO9

    Class II

See all devices from Bts SpA →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)