Manufacturer registered with FDA
鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG
FRIDINGEN, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 111,699 registrations outside the US
- Establishments
- 1Germany
Registered in 11 markets
Where regulators' registries name 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG 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 | 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG | 2 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | RUDOLF MEDICAL GMBH + CO. KG | 1,604 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Rudolf Medical GmbH + Co. KG | 36 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RUDOLF MEDICAL GMBH + CO. KG | 26 | 2012–2015 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | RUDOLF MEDICAL GmbH + Co. KG | 12 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | RUDOLF MEDICAL GMBH + CO. KGRudolf Medical GmbH CO. KG · RUDOLF Medical GmbH + Co. KG · +1 | 8 | 2007–2026 | Pure Global AI |
| China | NMPA | Registration holder | 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RUDOLF MEDICALRUDOLF MEDICAL GMBH + CO. KG · RUDOLF MEDICAL GMBH CO KG | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Rudolf Medical GmbHRudolf Medical GmbH + Co. KG | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Rudolf Medical GmbH + Co. KGRuDolf Medical GmbH + Co. KG | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RUDOLF MEDICAL GmbH + CO. KG | 1 | 2026–2026 | 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 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | — | 2004 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | — | 1977 |
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 |
|---|---|---|
| RUDOLF MEDICAL GMBH + CO. KGFDA reg. 8010298 | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010298). 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.