B.T.I. BIOTECHNOLOGY INSTITUTE, S.L
ES-MF-000001701 · Spain · Miñano
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L is registered in the European database on medical devices as a manufacturer, with 584 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 312 |
|---|---|
| Class IIb | 272 |
Among these devices, 272 are declared sterile, 272 implantable, 6 active.
Catalogue references include CIDT, CQ5, IIP3CA2565, INCIDA, IRPSCA5085, PUCU1.
European nomenclature codes declared: P01020101, Q010299, Q019005, V9099, S010499, Z12019099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. (ES) · FDA 3004417597 |
| Devices in EUDAMED | 584 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 584 |
|---|---|
| Found in the U.S. device database | 486 |
| Share | 83.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. |
What it holds in Canada
| Licences on record | 26 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| Class 3 devices | 13 |
| First licensed | 2011-09-30 |
Licence types: Device Family (15), Device Group Family (5), System (4), Device Group (1).
Licensed under: BTI SURGICAL DENTAL DRILLS, BTI COMPACTOR AND OSTEOTOME DRILLS, BTI IMPLANT MOUNT CONNECTORS, BTI RADIOGRAPHIC DIRECTION INDICATORS, BTI DENTAL IMPLANT EXTRACTION KIT, BTI DENTAL IMPLANT EXTRACTORS.
North American profile: Both markets. B.T.I. BIOTECHNOLOGY INSTITUTE, S.L is registered in both the United States and Canada.