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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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Sleep devices — 2 UDI-DI variants, MDR (Bittium Biosignals Oy)

MD Atlas
Bittium Biosignals Oy

Data from EUDAMED, last updated May 23, 2026

Sleep devices

643003522SleepDisordersT7

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Bittium Biosignals Oy

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Device characteristics

Active deviceMeasuring function

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 643003522SleepDisordersT7
Device name: Sleep devices
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Nov 4, 2025

Manufacturer & authorised representative

Manufacturer

Name: Bittium Biosignals Oy
SRN: FI-MF-000013983
Country: Finland
Email: bbs@bittium.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01GAT9SWWRMJ2D3ZZ4PPECG8KS

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

Bittium APV2006430035220526
940461206430035220540