Garmin International, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000037975 FEI 1000500214
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What Garmin International, Inc. makes
Garmin International, Inc. manufactures smartwatches and software applications, including the Garmin ECG App, designed for sports, leisure, outdoor, marine, road navigation, and aviation use.
The company is based in the US, and its portfolio includes Class IIa medical devices that are listed in the EUDAMED database.
Catalogue
Garmin ECG App Ref Smartphone ECG App Component
Regimes: CE MDR Registry: EUDAMEDGUDIDGarmin ECG App Ref Watch ECG App Component
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000037975
- FDA FEI number
- 1000500214
- DUNS number
- 791288004
- EUDAMED status
- Active
- EUDAMED registered name
- Garmin International, Inc.
- EUDAMED abbreviated name
- Garmin
- Registered address
- 1200, E 151st Street, 66062, Olathe, Kansas, United States
- Website
- www.garmin.com
- facebook.com/GarminD
- [email protected]
- PRRC contact
- Travis Johnson
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Oct 2029
DNV Product Assurance AS 2460 1 certificate
- C600563 Active
Quality management system EU MDR
- Issued
- 16 Oct 2024
- Expires
- 16 Oct 2029
From the company website
Discover innovative smartwatches and products for sports and leisure, outdoor, marine, road navigation and aviation.
Frequently asked questions
How many devices does Garmin International, Inc. have in the registry?
The registry currently lists 2 devices for Garmin International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Garmin International, Inc.'s devices?
Among its 2 most recently registered devices, Garmin International, Inc. has devices listed in EUDAMED (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Garmin International, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Garmin International, Inc.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Garmin International, Inc.?
EUDAMED lists 1 certificate for Garmin International, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 16 Oct 2024.
What are the newest devices from Garmin International, Inc. in the registry?
The most recently registered devices listed for Garmin International, Inc. include Garmin ECG App.