Manufacturer registered with FDA
Harald Nordin S.A.
Clarens, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1054 registrations outside the US
- Establishments
- 1Switzerland
Registered in 10 markets
Where regulators' registries name Harald Nordin S.A. 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 | Harald Nordin S.A. | 4 device types | — | Below |
| Taiwan | TFDA | Manufacturer | HARALD NORDIN SA | 19 | 2005–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Harald Nordin SAHARALD NORDIN SA · Harald Nordin Sa | 10 | 2000–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Harald Nordin SA | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HARALD NORDIN AS | 4 | 2011–2015 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Harald Nordin SA | 4 | 2024–2024 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | HARALD NORDIN SA | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 瑞诺丁公司Harald Nordin SA | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Harald Nordin SA | 2 | 2007–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Harald Nordin S.A. | 2 | — | 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 Harald Nordin S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | — | 2023 |
| Articulation PaperEFH · Class 1 | — | Maker | — | 2022 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | REAMER | 2005 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | MECODONT PARALLEL SIDED POSTSNORDIN CARBONITE CARBON FIBRENORDIN GLASSIX GLASS FIBRENORDIN GLASSIX PLUS GLASS FIBRENORDIN METAL SCREW POSTSOPTIFLEX POSTS | 1998 |
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 |
|---|---|---|
| HARALD NORDIN S.A.FDA reg. 8044177 | Montreux Vaud, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005988). 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.