Manufacturer registered with FDA
Aroa Biosurgery Ltd
Airport Oaks, New Zealand. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 12024–2024
- Markets registered in
- 12111 registrations outside the US
- Establishments
- 1New Zealand
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Aroa Biosurgery Ltd 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 | Aroa Biosurgery Ltd | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Aroa Biosurgery Ltd. | 69 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | AROA BIOSURGERY, LTD. | 13 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | AROA BIOSURGERY LTD. | 7 | 2018–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Aroa Biosurgery Ltd. | 4 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Aroa Biosurgery Ltd | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AROA BIOSURGERY LTD | 3 | 2019–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Aroa Biosurgery Limited | 3 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Aroa Biosurgery Ltd., | 3 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Aroa Biosurgery Limited | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Aroa Biosurgery Ltd | 1 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Aroa Biosurgery Ltd | 1 | 2024–2024 | 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 Aroa Biosurgery Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Aroa Dental MembraneEndoform Dental Membrane | 2024 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | Aroa Dental MembraneEndoform Dental Membrane | 2024 |
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 |
|---|---|---|
| Aroa Biosurgery LtdFDA reg. 3007321028 | Airport Oaks Auckland, New Zealand | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028943). 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.