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Tmjoint

FDA UDI

Class II (US FDA UDI)

by Bts Spa

Identity

Trade Name
TMJOINT FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature FDA UDI
Model / Reference
1.0 FDA UDI
Description
BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature FDA UDI

Identifiers

Catalog Number
BTSEMB1BM FDA UDI
Primary DI / UDI-DI
B179TMJ FDA UDI
FDA Product Code
HCC FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromyograph

Tmjoint by Bts Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyograph.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bts Spa

Sources (1)

  • FDA UDI 41ad9536-823d-4a0d-8786-4e3ce769f248 34 fields · synced Jun 8, 2026