OrthoPulse 2.0E (OPi2E-100)
Biolux Technology GmbH
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017271131 | 3017271131 | BIOLUX TECHNOLOGY GMBH | 1 | N | 2026-01-01 | Neubaugasse 31 Absdorf Niederosterreich AT 3462 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 09120118090029 | OrthoPulse - OPi | 8886690674 | support@orthopulse.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 291326 | 1898147490 | K230905 | OrthoPulse 2.0E (OPi2E-100) | PLH | 2023-06-09 |
| 291326 | 1974186863 | K143120 | OrthoPulse | PLH | 2015-07-24 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PLH | 2 | 2023-06-09 |
Biolux Technology GmbH
2026-03-11
2023-08-29
2022-07-16
2021-06-30