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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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Mandibular advancement devices — 6 UDI-DI variants, MDR (Oscimed SA)

MD Atlas
Oscimed SA

Data from EUDAMED, last updated May 23, 2026

Mandibular advancement devices

764010492SOMNOFIT8U

6 UDI-DI variants

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

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

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Device characteristics

No device characteristics flagged

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 764010492SOMNOFIT8U
Device name: Mandibular advancement devices
Device model: Mandibular Advancement devices
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Dec 7, 2022

Manufacturer & authorised representative

Manufacturer

Name: Oscimed SA
SRN: CH-MF-000009605
Country: Switzerland
Email: info@oscimedsa.com
Phone: +41329266336

Authorised representative

Name: OSCIMED EUROPE SAS
SRN: FR-AR-000028943
Country: France
Phone: +41329266336

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01GHZST3R51WB3PH0WQSKZH3S0

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

Bande Somnofit07640104927112
S-0207640104927006
SOMNOFIT-B Mandibular advancement device07640104927037
S-04-Pro07640104927020
S-0307640104927013
SLC-0107640104927105