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Biodex Medical Systems, Inc. © 2017
Product Certifications and Classifications
This product has received the following certifications and falls within the following
classifications:
•
ETL Listed Electrical Equipment, Laboratory Use; Part 1, General Requirements for
Safety conforms to UL 60601-1, CAN/CSA C22.2 No: 601-1-M90, IEC 60601-1, IEC
60601-1-4 and IEC 60601-1-2 and CE Marked.
•
FDA Class II Equipment
•
EC Certificate: EC #4132458
•
Type B Applied Part
•
Electromagnetic Compatibility: This equipment complies with the Medical
Equipment ICC 60601-2 EMC Standard.
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands