AKTIVE SRL
IT-MF-000007813 · Italy · ROMA
AKTIVE SRL is registered in the European database on medical devices as a manufacturer, with 1 045 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 045 |
|---|
Most frequent device types declared: Charles Cannulae Tips/Ago Charles, Fibre laser/ Laser Fiber, High pressure injection/aspiration system - Sistema di Iniezione/Aspir, Laser Fiber Extensible/Fibre Laser Estensibili, Laser Fiber Illuminated/Fibre Laser Illuminate.
Among these devices, 1 044 are declared sterile.
Devices declared under this manufacturer
- 23G Laser Probe, straight
- Aspiration Cannula 21G
- Laser Fiber 20G Straight Illuminated - Connector DRC - R
- Laser Fiber 20G Straight Illuminated - Connector QTL - K
- Laser Fiber 23G Straight Extensible - Connector SMA
- Laser Fiber 23G Straight Illuminated - Connector LMN - R
- Laser Fiber 25G Curved illuminated - Connector QTL - E
- Laser Fiber 27G Curved illuminated - Connector QTL - G
- Phaco Needle 19G Ang. 30° Curved 22° + Sleeve + T.Chamber + Wrench
- Phaco Needle 21G Ang. 30° (flared 20G) + Sleeve + T.Chamber + Wrench
- Retinal Chandelier 23G for Trocar - Connector S
- Retinal Chandelier 23G with Trocar - Connector D
Showing 12 of 1 045 declared devices.
Catalogue references include AK-0418/D, AK-0430/DRC-R, AK-0430/QTL-K, AK-0431/LMN-R, AK-0431/SMH, AK-0437/QTL-G.
European nomenclature codes declared: Q021199, Q020499, Q020699, Q021101, Q021109, Q021102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AKTIVE SRL (IT) · FDA 3012481881 |
| Devices in EUDAMED | 1 045 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 1 045 |
|---|---|
| Found in the U.S. device database | 291 |
| Share | 27.8 % |
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. AKTIVE SRL is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.22/5011.1 | reissued | 2027-12-13 |
EPT 0477.MDR.22/5010.1 | reissued | 2027-12-13 |