Data / Medical devices / United Kingdom / Mayborn (UK) Limited
Mayborn (UK) Limited: FDA-registered device maker in Newcastle upon Tyne, United Kingdom, 1 510(k) clearance
Mayborn (UK) Limited is registered with the FDA (registration 3008729914) in Newcastle upon Tyne, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008729914
- Address
- Mayborn House Balliol Business Park, Newcastle upon Tyne, United Kingdom, NE12 8EW
- Owner or operator
- Mayborn Group Limited (10034113)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 6, 2010
- Registered through
- 2026
- Brand names listed
- TT Wearable Breast Pump, Tomme Tippee Silicone Breast Pump, Tommee Tippee, Tommee Tippee Manual Breast Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Specification developer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Specification developer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2022 | K221598 | Wearable breast pump | HGX | Substantially Equivalent | Mayborn (Uk) Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Pump, Breast, Non-Powered
Updated December 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.