Manufacturer registered with FDA
Raumedic AG
Helmbrechts, Germany. 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
- 1165 registrations outside the US
- Establishments
- 1Germany
Registered in 11 markets
Where regulators' registries name Raumedic AG 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 | Raumedic AG | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Raumedic AG | 14 | 2015–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | RAUMEDIC AG | 12 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | RAUMEDIC AG | 12 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RAUMEDIC AG | 10 | 2007–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RAUMEDIC AG | 5 | 2024–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | RAUMEDIC AG | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Raumedic AGraumedic AG | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | RAUMEDIC AGRaumedic | 2 | 2021–2025 | Pure Global AI |
| China | NMPA | Registration holder | 诺美德科股份有限公司RAUMEDIC AG | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RAUMEDIC AG | 1 | 2018–2018 | 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 Raumedic AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | — | 2015 |
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 |
|---|---|---|
| RAUMEDIC - MuenchbergFDA reg. 3006946348 | Helmbrechts Bavaria, Germany | Contract manufacturer |
Other names on FDA records
RAUMEDIC - Muenchberg
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024509). 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.