EUDAMED device

Body Temperature Software

EUDAMED device 00810073612327 · Fitbit LLC

Key facts

Primary DI 00810073612327
Trade name Body Temperature Software
Device name Body Temperature Software
Reference or catalog number FB611
Manufacturer Fitbit LLC
Manufacturer SRN US-MF-000007439
Risk class Class IIa
EMDN code V030199
EMDN description BODY TEMPERATURE MEASURING DEVICES - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jul 14, 2024

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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