Registered with FDA
Mayborn Group Limited
Newcastle upon Tyne, United Kingdom. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 2United Kingdom, United States
Registered in 2 markets
Where regulators' registries name Mayborn Group Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Mayborn Group Limited | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Mayborn (UK) Limited | 1 | — | 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 Mayborn Group Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Lister | Tommee Tippee | 2010 |
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 |
|---|---|---|
| Mayborn (UK) LimitedFDA reg. 3008729914 | Newcastle upon Tyne, United Kingdom | Repacker / relabeler |
| Mayborn USA Inc.FDA reg. 3011584003 | Stamford, CT, United States | Repacker / relabeler |
Other names on FDA records
Mayborn (UK) Limited · Mayborn USA Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034113). 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.