Public EUDAMED Search

EUDAMED Device Search

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

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24.09.2026 04:37

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Active filter:Manufacturer SRN:US-MF-000007439

7 device results listed.

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Fitbit ECG App

FB603

Class IIaMDDOn the marketActive device

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810038851983
Basic UDI-DI: B-00810038851983
Reference: FB603
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:30

Manufacturer products Authorised representative products Authorised representative actors View details

Google ECG app

GA13098

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810028737815
Basic UDI-DI: 081003885FB603R8
Reference: GA13098
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Google Irregular Rhythm Notifications

FB604

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810028737778
Basic UDI-DI: 081003885FB604RA
Reference: GA13099
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Breathing Emergency Detection

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810028736795
Basic UDI-DI: 081002873GA11010DB
Reference: GA11010
EMDN: Z12039092
EMDN description: VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.07.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

Loss of Pulse Detection

FB612

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810073612334
Basic UDI-DI: 081007361FB612NG
Reference: FB612
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Body Temperature Software

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810073612327
Basic UDI-DI: 081007361FB611NE
Reference: FB611
EMDN: V030199
EMDN description: BODY TEMPERATURE MEASURING DEVICES - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fitbit Irregular Rhythm Notifications

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810038852720
Basic UDI-DI: 081003885FB604RA
Reference: FB604
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details