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.
Catalogue references include MKT, OPTIFLEX HA 10mg/ml, 1 ml PFS, OPTIFLEX HPMC 2 ml PFS, Opti Blue, 1 ml PFS, Optiflex HA 14mg/ml, 1ml PFS, Optiflex HA 24mg/ml, 1ml PFS.
European nomenclature codes declared: Q02030301, Q02030201, Q02030399, Q0299.
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 |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Biotech Europe Meditech Inc Limited is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C537156 | issued | 2027-05-13 |