Registered with FDA
simex Medizintechnik GmbH
DEISSLINGEN, Germany. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 723 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name simex Medizintechnik 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 | simex Medizintechnik GmbH | 8 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Simex Medizintechnik GmbH | 10 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | simex Medizintechnik GmbH | 7 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SIMEX MEDIZINTECHNIK GMBH | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | simex Medizintechnik GmbH | 2 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | simex Medizintechnik GmbH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Simex Medizintechnik GmbH | 1 | 2021–2021 | 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 simex Medizintechnik 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 | Mirror, Mouth | 2022 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Tray, Impression, Preformed | 2022 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Syringe, Periodontic, Endodontic, Irrigating | 2022 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Retractor, All Types | 2022 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | Forceps, Rongeur, Surgical | 2022 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Elevator, Surgical, Dental | 2022 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | Scaler, Periodontic | 2022 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Lister | Curette, Periodontic | 2022 |
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 |
|---|---|---|
| SIMEX MEDIZINTECHNIK GMBHFDA reg. 3005813597 | Deisslingen Baden-Wurttemberg, Germany | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9086230). 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.