B&B Medical Technologies has received ISO 13485 Certification and Health Canada Medical Device Licenses to sell the B&B Bubbler and HOPE Nebulizer into the Canadian market, according to a company news announcement.
The B&B Bubbler Water Seal CPAP Valve is intended to provide breathing support to spontaneously breathing neonates and infants where CPAP has been prescribed by a physician.
The HOPE Nebulizer is a high output nebulizer used for delivery of aerosolized medications and diagnostic formulations.
“This is another step in B&B strengthening our global expansion efforts,” said Stu Novitz, Vice President of Sales and Marketing. “We have had loyal customers in many international markets including Canada for years and look forward to building on these relationships as well as forging new ones in other countries.”
To this end, B&B’s global strategy also includes CE approval for its Class II medical devices. “We are currently in this process and expect to have the necessary certifications and approvals later this year to sell the Bubbler and HOPE Nebulizer in Europe,” according to Derick Corrente, Director of Operations.
More information is available on the company’s website.