Stockholm, Sweden-based Blueair AB, maker of room air purifiers and parent company of Chicago, IL, U.S.-based Blueair, Inc., announced it has been listed by the U.S. Food and Drug Administration (FDA) as a "Medical Device Establishment."
The company listed its complete line of air purifiers with the FDA that included the Model 601 with a room capacity of 679 sq ft, the Model 501 with a room capacity of 620 sq ft, and the Model 402 with a room capacity of 379 sq ft.
"The FDA listing sets Blueair apart from everyday low cost, low quality, mass-produced air purifiers," said Bengt Rittri, president of Blueair, Inc. "It also assures the consumer of superior quality and performace.
As a manufacturer of medical devices, the company operates under FDA guidelines for good manufacturing practices (GMP) and is subject to occasional FDA inspections. The GMP regulations include requirements related to the methods used in and the facilities and controls for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices.
The company also announced it registered Guenter Ginsberg, president of Media Trade Corporation (Bonita Springs, FL, U.S.) with the FDA as its "FDA United States Agent" and "Official Correspondent for all dealings with the agency.
to Daily News