LM-Instruments Oy
FI-MF-000006705 · Finland · Parainen
LM-Instruments Oy is registered in the European database on medical devices as a manufacturer, with 2 639 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 639 |
|---|
Most frequent device types declared: An endodontic hand instruments for root canal reparation, Hand instrument for tooth extraction, Tip for an Ultrasonic scaler, Ultrasonic device for professional dental care, built-in, Dental hand instrument, excavator for preparation of root canal.
Among these devices, 1 411 are declared reusable, 23 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LM-INSTRUMENTS OY (FI) · FDA 8032033 |
| Devices in EUDAMED | 2 639 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1080-826-23 | supplemented | 2028-09-11 |