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Breathing Emergency Detection

by Fitbit LLC

Ref GA11010

Breathing Emergency Detection (GA11010) is a Class IIa device made by Fitbit LLC, registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI 081002873GA11010DB), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081002873GA11010DB Basic UDI-DI 00810028736795UDI-DIDate22 Jul 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
GA11010
Primary DI / UDI-DI
00810028736795
Basic UDI-DI
081002873GA11010DB
Direct marketing DI
00810028736795
EMDN code
Z12039092 Various instruments to support and monitor vital signs - medical device software
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007439
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE.

Other devices from Fitbit LLC

See all devices from Fitbit LLC →

Properties

Other properties (14, all answered No)