Regulatory Information

Curlin Medical is ISO 13485:2003 certified and complies with 21 CFR Part 820 - Quality System Regulation, Canadian Medical Device Regulations PC 1998-783, and all other applicable regulatory requirements. Our patented products have received the "CE" mark and are in compliance with the Medical Devices Directive 93/42/EEC.

The links below are in PDF format.

Certificates and Licenses:

• Quality Systems Certificate - ISO 13485:2003
• Quality Systems Certificate - CAN/CSA-ISO 13485:2003
• Quality Systems Certificate - 93/42/EEC, Annex II (Infusion Pumps & Accessories)
• Quality Systems Certificate - 93/42/EEC, Annex II (beeLINE® Infusion System)
• Quality Systems Certificate - 93/42/EEC, Annex II (Catheter Accessory Pack)
• Device Manufacturing License - State of California
• Joint Commission Accreditation Health Organization (JCAHO)
• Certificate To Foreign Government
• Canada Medical Device Licenses
• Sterile Disposable Administrative Sets
• Curlin Ambulatory Infusion Pump
• beeLINE® Infusion System
• Compliance to IEC 60601-1 and IEC 60601-2-24
• Electromagnetic Compatibility-Report for 4000-CMS
• Electromagnetic Compatibility-Report for 6000-CMS

FDA Establishment Registration

Curlin Medical Inc.
15751 Graham Street
Huntington Beach, California 92649-1630
USA

510(k) Premarket Notification

• K981816 Curlin Ambulatory Pumps / Curlin Administration Sets
• K042228 beeLINE® motIV® Infusion Pump System and Kit
• K050770 ACCUFUSER® System, ACCUFUSER® Plus and Standard Procedure Kit
• K023491 AutoMed® 3300 and 3400 Pump Systems
• K023863 AutoMed® 3000 Infusion Pump
• K023973 AutoMed® 3200 Infusion Pump

For Regulatory information, please contact:

Director of Regulatory Affairs / Quality Assurance
714.893.2200
info@CurlinMedical.com