Fridababy, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000044395 FEI 3030726486
Fridababy, LLC is a medical device manufacturer based in the United States, with 74 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I and IIa; FDA Class II and Unclassified) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 74
- Registrations
- EUDAMEDFDA
- FDA recalls
- 10 ongoing since 2021 (1 open in total)
Registry facts
- Registries
- EUDAMED 64
- FDA GUDID 9
- FDA 510(k) 1
- Device classes
- EU Class I 36
- EU Class IIa 28
- FDA Class II 8
- FDA Unclassified 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Nasalprodukter Sverige AB authorised representative
- Identifiers
- EUDAMED SRN US-MF-000044395
- FDA FEI 3030726486
- DUNS 783729598
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Nasalprodukter Sverige ABSE
Catalogue
Search and filter all 74 devicesShowing 1-50 of 74
Company details
- EUDAMED SRN
- US-MF-000044395
- SRN (system / procedure pack)
- US-PR-000055127
- FDA FEI number
- 3030726486
- DUNS number
- 783729598
- EUDAMED status
- Active
- EUDAMED registered name
- Fridababy, LLC
- Registered address
- 82 NE 26 th Street Miami, 33137, Miami, Florida, United States
- Website
- frida.com
- Phone
- (305) 673-7535
- PRRC contact
- Daniela Davila
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 27 Jan 2020 Z-1103-2020 Class II Open since 2020 FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
Full distribution text
- 27 Jan 2020 Z-1103-2020 Class II Open since 2020 FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
Frequently asked questions
How many devices does Fridababy, LLC have in the registry?
The registry currently lists 74 devices for Fridababy, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fridababy, LLC's devices?
Among its 50 most recently registered devices, Fridababy, LLC has devices listed in EUDAMED (41 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Fridababy, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Fridababy, LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fridababy, LLC?
FDA recall records list 1 recall initiated by Fridababy, LLC, the most recent initiated on 27 Jan 2020. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fridababy, LLC in the registry?
The most recently registered devices listed for Fridababy, LLC include NoseFrida Saline Snot Spray, Nosefrida the Snotsucker Saline Kit, Compresas Frías de Alivio Rápido + Braguitas Desechables para Postparto and Spazzola per il bagno dalla testa ai pied.