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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Bruxism Monitor Device — 1 UDI-DI variant, MDR (OT Bioelettronica srl)

MD Atlas
OT Bioelettronica srl

Data from EUDAMED, last updated May 30, 2026

Bruxism Monitor Device

805697785BRUXP003PN

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: OT Bioelettronica srl

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 805697785BRUXP003PN
Device name: —
Device model: Bruxism Monitor Device
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: May 8, 2023

Manufacturer & authorised representative

Manufacturer

Name: OT Bioelettronica srl
SRN: IT-MF-000033348
Country: Italy
Email: a.bottin@otbioelettronica.it
Phone: +3901119720518

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01GZXKKDM1MTW7XFQX4Y8GECHQ

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

OT016408056977850089