United States Approvals

Establishment Registration
K992551 - Alpha Infusion Pump System
K021964 - Alpha Infusion Pump and Catheters
K042246 - Multi Drip Infusion Catheters
K061356 - Polyurethane Infusion Catheters
K061661 - STA Cath Attachable Infusion Catheters
K071532 - Alpha Infusion Pump Silicone Chambers
International Approvals

Quality Systems Certificate - 93/42/EEC
Quality Systems Certificate - DIN EN ISO 13485
Quality Systems Certificate - CMDCAS ISO 13485
Health Canada - Alpha Infusion Pumps
Health Canada - Alpha Cath Catheters
Health Canada - Multi Drip Catheters
Health Canada - STA Cath Catheters
Certificate to Foreign Governments
Declaration of Conformity- Alpha Infusion Pump
Declaration of Conformity- STA Cath Catheter
Declaration of Conformity- Polyurethane Catheters
Declaration of Conformity- Introducers

European Authorized Representative

Donawa Lifesciences SM
Piazza Albania, 10
00153 Rome, Italy

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