Registered with FDA
Amnotec International Medical GmbH
Neuhausen ob Eck, Germany. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 123,319 registrations outside the US
- Establishments
- 1Germany
Registered in 12 markets
Where regulators' registries name Amnotec International Medical GmbH 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 | Amnotec International Medical GmbH | 12 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | AMNOTEC International Medical GmbH | 3,002 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Amnotec international medicalAmnotec International Medical GmbH · AMNOTEC International Medical GmbH · +2 | 211 | 2013–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | AMNOTEC International Medical GmbH | 63 | 2022–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AMNOTEC International Medical GmbH | 13 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AMNOTEC INTERNATIONAL MEDICAL GMBH | 7 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | AMNOTEC International Medical GmbH | 6 | — | Pure Global AI |
| China | NMPA | Registration holder | 安泰国际医疗有限公司AMNOTEC International Medical GmbH | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | AMNOTEC International Medical GmbH | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AMNOTEC INTERNATIONAL MEDICAL GMBHAMNOTEC International Medical GmbH | 3 | 2020–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | AMNOTEC International Medical GmbH | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AMNOTEC INTERNATIONAL MEDICAL GMBH | 2 | 2023–2023 | 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 Amnotec International Medical GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | — | 2021 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | London College | 2018 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | — | 2022 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | — | 2021 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | — | 2021 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | — | 2018 |
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 |
|---|---|---|
| AMNOTEC INTERNATIONAL MEDICAL GMBHFDA reg. 3014615697 | Neuhausen ob Eck Baden-Wurttemberg, Germany | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057846). 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.