Manufacturer registered with FDA
DuPhaMed B.V.
ALPHEN AAN DEN RIJN, Netherlands. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1Netherlands
Registered in 2 markets
Where regulators' registries name DuPhaMed B.V. 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 | DuPhaMed B.V. | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | DuPhaMed B.V. | 4 | — | 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 DuPhaMed B.V. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Maker | bite block hygiene sleeve/barrier, several sizesdigital sensor hygiene sleeve/barrier, several sizesdigital sensor positioners, intraoral, Bite wing/Posterior/Periapical/Endo, size 1 and 2Foam Bites for edentulous patienthygiene sleeve/barrier for ear cone, cephalometric imagingOPG bite block sleeveOPG head support stripphosphor plate hygiene sleeve/barrier, sizes 0, 1, 2, 3 and 4phosphor plate positioner kitphosphor plate positioners, intraoral, Bite wing/Posterior/Periapical/Endo, size 1 and 2 5 morePositioning ring for sensor/phophor plate holderssensor positioner kit, size 1 and 2wall mount for digital x-ray intraoral sensorx-ray phosphor plate hygiene sleeveX-ray sensor hygiene sleeve | 2020 |
| X-Ray CollimatorEHB · Class 1 | — | Maker | dental x-ray sensor holder | 2006 |
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 |
|---|---|---|
| DUPHAMED B.V.FDA reg. 3005739556 | ALPHEN AAN DEN RIJN Zuid-Holland, Netherlands | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9087279). 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.