Manufacturer registered with FDA
Mediplast AB
MALMO, Sweden. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9154 registrations outside the US
- Establishments
- 1Sweden
Registered in 9 markets
Where regulators' registries name Mediplast AB 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 | Mediplast AB | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Mediplast ABMEDIPLAST SRL | 62 | 2002–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Mediplast AB | 44 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Mediplast AB | 29 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | MEDIPLAST SASMEDIPLAST LTDA. | 13 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Mediplast AB | 2 | 2022–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Mediplast AB | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MEDIPLAST AB | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDIPLAST | 1 | 2005–2005 | 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 Mediplast AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Mediplast Evacuator, oral cavity | 1991 |
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 |
|---|---|---|
| MEDIPLAST ABFDA reg. 8020659 | MALMO Skane, Sweden | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9003376). 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.