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US-MF-000007439GCQ 108854 0002Fitbit ECG App is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Fitbit LLC. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 13, 2022
B-00810038851983Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00810038851983
12 warnings recorded — scroll inside the panel to see all entries.
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Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in XI; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | Oct 7, 2020 | Sep 9, 2022 |
| Austria | Oct 7, 2020 | Sep 9, 2022 |
| Belgium | Oct 7, 2020 | Sep 9, 2022 |
| Czechia | Oct 7, 2020 | Sep 9, 2022 |
| Germany | Oct 7, 2020 | Sep 9, 2022 |
| Spain | Oct 7, 2020 | Sep 9, 2022 |
| France | Oct 7, 2020 | Sep 9, 2022 |
| Ireland | Oct 7, 2020 | Sep 9, 2022 |
| Italy | Oct 7, 2020 | Sep 9, 2022 |
| Luxembourg | Oct 7, 2020 | Sep 9, 2022 |
| Netherlands | Oct 7, 2020 | Sep 9, 2022 |
| Norway | Oct 7, 2020 | Sep 9, 2022 |
| Poland | Oct 7, 2020 | Sep 9, 2022 |
| Portugal | Oct 7, 2020 | Sep 9, 2022 |
| Romania | Oct 7, 2020 | Sep 9, 2022 |
| Sweden | Oct 7, 2020 | Sep 9, 2022 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00810038851983Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-00810038851983FB603UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12050382ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIESNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.