FDA Registration
Active
🇮🇹 Italy
High pressure injection/aspiration system for syringe - Connector H(H2)
Reg #: 3012481881
·
FEI: 3012481881
·
Expires 2025
Products
1
Proprietary Names
77
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AKTIVE SRL
- Registration Number
- 3012481881
- FEI Number
- 3012481881
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA GIACOMO DELITALA, 106
- City
- Rome Lazio
- Country
- IT
Owner / Operator
- Firm Name
- AKTIVE SRL
- Operator Number
- 10087294
- Address
- VIA GIACOMO DELITALA, 106
- City
- Rome
- State
- Lazio
- Postal Code
- 00173
- Country
- IT
- Correspondent
- ANDREA CHINI
US Agent
- Business Name
- Oftal-one Inc.
- Contact Name
- Elena Morozova
- Address
- 250 Catalonia Ave, Suite 506
- City
- Coconut Grove
- State
- FL
- ZIP
- 33134
- Country
- US
- [email protected]
- Phone
- 305 4694243
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2023-02-13 |
Proprietary Names
High pressure injection/aspiration system for syringe - Connector H(H2)
Assisted Infusion set A3
Dual Bore Cannula 25G, 36mm
High pressure injection/aspiration system for syringe - Connector G
High pressure injection/aspiration system for syringe - Connector B (B2)
Full Handle Backflush 27G Soft tip Extensible Active/Passive
Full Handle Backflush 20G Brush tip Extensible Active/Passive
Passive Reservoir
Full Handle Backflush 27G Soft tip Active/Passive (1,5 mm)
High pressure injection/aspiration system for syringe - Connector D (D2)
Full Handle Backflush 23G Soft tip Active/Passive (1.5 mm)
Tubing set A4
Full Handle Backflush 23G Soft tip Active/Passive
Full Handle Backflush 27G Brush tip Active/Passive
Dual Bore Cannula 23G, 36mm
Full Handle Backflush 20G Soft tip Extensible Active/Passive
Tubing set A5
Assisted Infusion set D2
Full Handle Backflush 25G Standard Active/Passive
Full Handle Backflush 20G Soft tip Active/Passive
High pressure injection/aspiration system for syringe - Connector F
Air/fluid tubing D8
Full Handle Backflush 25G Brush tip Active/Passive
Infusion/Aspiration tubing A1
High pressure injection/aspiration system for syringe - Connector C (C2)
High pressure injection/aspiration system with syringe - Connector B
Dual Bore Cannula 20G
High pressure injection/aspiration system for syringe - Connector A (A2)
Full Handle Backflush 20G Brush tip Active/Passive
Air injection tube 140 cm
High pressure injection/aspiration system for syringe - Connector E (E2)
Dual Bore Cannula 23G
Air injection tube 70 cm
Full Handle Backflush 23G Brush tip Active/Passive
High pressure injection/aspiration system with syringe - Connector F
Full Handle Backflush 23G Soft tip Extensible Active/Passive
Full Handle Backflush 23G Brush tip Extensible Active/Passive
Assisted Infusion set K1
Tubing set D7
Air injection tube 200 cm
Set Bi-manual I/A Handpieces 23G
High pressure injection/aspiration system with syringe - Connector D
Tubing set D4
High pressure injection/aspiration system with syringe - Connector A
Infusion/Aspiration tubing D3
High pressure injection/aspiration system with syringe - Connector C
High pressure injection/aspiration system for syringe - Connector C
Full Handle Backflush 27G Soft tip Active/Passive
Dual Bore Cannula 25G
Full Handle Backflush 27G Brush tip Active/Passive (1,5 mm)
Set Bi-Manual I/A Handpieces 21G
Full Handle Backflush 23G Brush tip Active/Passive (1,5 mm)
Air/fluid tubing A2
High pressure injection/aspiration system for syringe - Connector H
Full Handle Backflush 27G Standard Active/Passive
Tubing set D5
Full Handle Backflush 23G Standard Active/Passive
Tubing set D6
Full Handle Backflush 20G Standard Active/Passive
High pressure injection/aspiration system for syringe - Connector B
Infusion/Aspiration tubing D1
Full Handle Backflush 25G Soft tip Active/Passive (1,5 mm)
High pressure injection/aspiration system with syringe - Connector H
High pressure injection/aspiration system for syringe - Connector A
High pressure injection/aspiration system with syringe - Connector G
Active Reservoir
High pressure injection/aspiration system for syringe - Connector D
Full Handle Backflush 25G Soft tip Extensible Active/Passive
High pressure injection/aspiration system for syringe - Connector F (F2)
Dual Bore Cannula 27G
High pressure injection/aspiration system for syringe - Connector E
High pressure injection/aspiration system for syringe - Connector G (G2)
Full Handle Backflush 25G Soft tip Active/Passive
Full Handle Backflush 25G Brush tip Extensible Active/Passive
Full Handle Backflush 25G Brush tip Active/Passive (1,5 mm)
Full Handle Backflush 27G Brush tip Extensible Active/Passive
High pressure injection/aspiration system with syringe - Connector E
Establishment Types
Manufacture Medical Device