Biotecnica Instruments S.r.l.
IT-MF-000008115 · Italy · Roma
Biotecnica Instruments S.r.l. is registered in the European database on medical devices as a manufacturer, with 145 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
Most frequent device types declared: AUTOLYSER, AUTOLYSER 450, BT 1500, BT 1500i, BT 3000 PLUS.
Devices declared under this manufacturer
- AUTOLYSER
- BT 4500S S/ISE
- BT15i
- CB350i S/UPS-STAMPANTE
- Cuvette Wash Solution
- DETERG. CAMERA MISCELAZIONE
- FCC SOLUTION TARGA
- I.S.E. SOLUZIONE RIFERIMENTO
- ISE Reference Sol.
- ISE Reference conc.
- ISE Wash Solution
- SOLUZIONE CLEANING
Showing 12 of 145 declared devices.
Catalogue references include 390, 395E, AUTOLYSER-C-D, BT 3500-A, BT15i-B-F, CB350i-A.
European nomenclature codes declared: W0201010101, W0599, W0201010102, W0101070304, W0201010105.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | BIOTECNICA INSTRUMENTS, Srl (IT) · FDA 1000455123 |
| Devices in EUDAMED | 145 |
| Country of registration | Italy |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 145 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 1.4 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.