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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

23.07.2026 13:10

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Active filter:Manufacturer SRN:FI-MF-000013983

34 device results listed.

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360

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-Faros360X9
Basic UDI-DI: B-Faros360X9
Reference: 9404300
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 23:30

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180

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-Faros180X5
Basic UDI-DI: B-Faros180X5
Reference: 9404302
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 23:30

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180L

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-Faros180L2W
Basic UDI-DI: B-Faros180L2W
Reference: 9404659
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 23:30

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14D

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-Faros14DXX
Basic UDI-DI: B-Faros14DXX
Reference: 9305243
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 23:30

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D-CardiacNavigator6U

Cardiac Navigator

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-CardiacNavigator6U
Basic UDI-DI: B-CardiacNavigator6U
Reference: 9404256
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 14:14

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D-BrainStatus5L

BrainStatus

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-BrainStatus5L
Basic UDI-DI: B-BrainStatus5L
Reference: 9305030
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:32

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APV20

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-APV20XN
Basic UDI-DI: B-APV20XN
Reference: 9404611
EMDN: V0399
EMDN description: MEASUREMENT DEVICES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 12.07.2026 21:36

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Sleep Device Accessories

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221226
Basic UDI-DI: 643003522SleepDevAc3P
Reference: 9305407
EMDN: -
EMDN description: VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Respiro RIP Belt Short

Respiro Accessories

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221127
Basic UDI-DI: 643003522RespiroAccLK
Reference: S0000020345
EMDN: -
EMDN description: MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Fast-Fix Electrode

Fast-Fix Electrodes

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221110
Basic UDI-DI: 643003522Fast-FixL8
Reference: 901155
EMDN: -
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium Physior

Bittium Physior

Class IMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221042
Basic UDI-DI: 643003522BittiumPhysiorFB
Reference: S0000023073
EMDN: -
EMDN description: ELECTROMYOGRAPHS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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IEC 2-electrode 1-CH patient cable 125 mm

ECG Patient Cable

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221035
Basic UDI-DI: 643003522PatientCableF5
Reference: S0000022709
EMDN: -
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium MedicalSuite Center

MedicalSuite Center v3.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221028
Basic UDI-DI: 643003522SuiteCYA
Reference: S0000022661
EMDN: -
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium MedicalSuite Mobile

MedicalSuite Mobile v3.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221011
Basic UDI-DI: 643003522SuiteMYW
Reference: 9530433
EMDN: -
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium MINI UL

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220885
Basic UDI-DI: 643003522Cardiac3Z
Reference: S0000018246
EMDN: -
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium Respiro Analyst

Sleep apnea test analysis software

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220762
Basic UDI-DI: 643003522SleepAnalysisFC
Reference: 9530488
EMDN: -
EMDN description: MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Sleep devices

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220526
Basic UDI-DI: 643003522SleepDisordersT7
Reference: 9404613
EMDN: -
EMDN description: MEASUREMENT DEVICES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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OmegaSnap 1-CH ECG Electrode

OmegaSnap

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220519
Basic UDI-DI: 643003522ECGElectrodeTY
Reference: 9404644
EMDN: -
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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BrainStatus EEG electrode

EEG electrodes

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220427
Basic UDI-DI: 643003522EEGElectrodeVW
Reference: 9404296
EMDN: -
EMDN description: EEG ELECTRODES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:53

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Bittium Respiro

-

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220540
Basic UDI-DI: 643003522SleepDisordersT7
Reference: 9404612
EMDN: -
EMDN description: MULTI-FUNCTIONAL POLYGRAPHIC SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 24.06.2026 17:34

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