Covidien EC Certificates and Declarations of Conformity

Covidien, 5920 Longbow Drive, Boulder, Colorado, markets advanced electrosurgical, ultrasonic surgical, and radiofrequency ablation and lesioning systems worldwide. Doing business on a worldwide basis requires medical device manufacturers to conform to international quality system standards. The International Organization for Standardization (ISO) 9000 series Quality System standards have evolved to include derivatives, which have been customized to different types of industries. ISO 13485:2003 is the derivative stand alone Quality Management Standard, which is applicable to the medical device industry throughout the world. This certificate, FM 71825, which also meets the Canadian Medical Devices Conformity Assessment System (CMDCAS) requirements was issued by the British Standards Institution.

As of 14 June 1998, all medical devices sold within the member states of the European Union are required to bear the CE mark. Affixing the CE mark to higher risk devices requires an audit of the company’s quality system by a Notified Body. This is to ensure the company meets the requirements of the European communities’ Medical Device Directive (93/42/EEC) and EN/ISO 13485. BSI issued EC certificates CE 00500 and CE 01948 to Covidien.

In addition to affixing the CE mark to product, each manufacturer must also issue a Declaration of Conformity, which attests that the product meets all of the applicable requirements. Covidien has issued Declarations of Conformity for the following product families (Click on the product family to view the applicable Declaration of Conformity):

• Accessories (Declaration Number 301)
• Argon (GSU) System (Declaration Number 302)
• Cables and Cords (Declaration Number 303)
• Active Electrodes (Declaration Number 306)
• Electrosurgical Generators (Declaration Number 307A)
• Electrosurgical Pencils (Declaration Number 309)
• Suction Coagulators (Declaration Number 310)
• Electrosurgical Forceps (Declaration Number 312)
• Laparoscopic Handpieces and Electrodes (Declaration Number 313)
• Return Electrodes (Declaration Number 314)
• Smoke Evacuation Devices (Declaration Number 315)
• Electrosurgical Vessel Sealing Devices (Declaration Number 316)
• RF Ablation System (Declaration Number 319)
• Microwave Ablation System (Declaration Number 323)
• Pumps (with machinery directive) (Declaration Number 325)
• RF Ablation System (Declaration Number 326)
• RF Ablation System Accessories (Declaration Number 327)
• RF Ablation System Pump (Declaration Number 328)

Questions concerning Covidien regulatory certifications should be directed to:

Regulatory Department
Covidien
5920 Longbow Drive
Boulder, CO 80301-3299 USA
303-530-2300