Manufacturer registered with FDA
麦迪卡有限公司 MedicNRG Ltd
AFULA, Israel. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 622 registrations outside the US
- Establishments
- 1Israel
Registered in 6 markets
Where regulators' registries name 麦迪卡有限公司 MedicNRG Ltd 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 | 麦迪卡有限公司 MedicNRG Ltd | 4 device types | — | Below |
| Canada | Health Canada | Registration holder | MEDIC NRG LTD. | 9 | 2008–2011 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDICNRG LTD.MEDIC NRG LTD. | 6 | 2013–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | MedicNRG LTD.MEDICNRG LTD. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MedicNRG LtdMedicNRG Ltd. | 2 | 2008–2013 | Pure Global AI |
| China | NMPA | Registration holder | 麦迪卡有限公司 MedicNRG Ltd | 1 | — | 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 麦迪卡有限公司 MedicNRG Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | LIGHT, FIBER OPTIC, DENTALLumiNRG | 2008 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | GentlefileGentlefile BrushGentlefile Endo File | 2020 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | GentlefileGentlefile BrushGentlefile Endo File | 2017 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Gentlefile Drive | 2020 |
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 |
|---|---|---|
| MICRO DIAMOND TECHNOLOGIES LTD.- MEDICNRG LTD.FDA reg. 3006531065 | AFULA Northern, Israel | Manufacturer |
Other names on FDA records
Micro Diamond Technologies LTD.- Medicnrg Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9094820). 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.