Manufacturer registered with FDA
Fridababy, LLC
Miami, FL, United States. Lists 3 dental device types with FDA across 2 registered establishments.
- Device types listed
- 3
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 638 registrations outside the US
- Establishments
- 2United States
Registered in 6 markets
Where regulators' registries name Fridababy, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Fridababy, LLC | 3 device types | — | Below |
| European Union | EUDAMED | Registration holder | Fridababy, LLC | 16 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Fridababy, LLC | 10 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | FRIDABABY, LLC | 6 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Fridababy LLC | 5 | 2022–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FRIDABABY, LLC | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Fridababy, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Baby Grooming KitFridababy Finger ToothbrushFridababy Grow-With-Me Training Toothbrush SetFridababy Training Toothbrush for BabiesFridababy Training Toothbrush for ToddlersFridababy Triple-Angle ToothhuggerSmile Frida Kit | 2016 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Not-Too-Cold-To-Hold Teether | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | — | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FridaBaby LLCFDA reg. 3005630901 | Miami, FL, United States | Complaint file establishment, Specification developer |
| FRIDABABY, LLCFDA reg. 3030726486 | Jacksonville, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052488). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.