Biotech Europe Meditech Inc Limited
IE-MF-000004695 · Ireland · Roscommon
Biotech Europe Meditech Inc Limited is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 5 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: BES22,BES28,BES28P.
Among these devices, 6 are declared sterile.
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 | BIOTECH EUROPE MEDITECH INC LTD (IE) · FDA 3016942176 |
| Devices in EUDAMED | 6 |
| Country of registration | Ireland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C537156 | issued | 2027-05-13 |