Registered with FDA
HA2 Medizintechnik GmbH
Halberstadt, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 224 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name HA2 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 | HA2 Medizintechnik GmbH | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HA2 MEDIZINTECHNIK GMBH | 24 | — | 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 HA2 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 |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Transcodent Dental Needle | 2022 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | Creos xenoprotect, Kontour Matrix, Zmatrix | 2024 |
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 |
|---|---|---|
| HA2 MEDIZINTECHNIK GMBHFDA reg. 3009039068 | Halberstadt Saxony-Anhalt, Germany | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042677). 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.