Registered with FDA
Systagenix Wound Management Manufacturing Limited
North Yorkshire, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 524 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 5 markets
Where regulators' registries name Systagenix Wound Management Manufacturing 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 | Systagenix Wound Management Manufacturing Limited | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Systagenix Wound Management Manufacturing LimitedSystagenix Wound Management Manufacturing Ltd. | 12 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITEDSystagenix Wound Management Manufacturing Limited | 9 | 2005–2016 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Systagenix Wound Management Manufacturing Limited | 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 Systagenix Wound Management Manufacturing 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 |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | — | 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 |
|---|---|---|
| Systagenix Wound Management Manufacturing LimitedFDA reg. 3007663067 | North Yorkshire, United Kingdom | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028771). 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.