Since 1965, Busse Hospital Disposables has manufactured single-use medical devices and supplies for the healthcare industry from its U.S. facility. The Hauppauge company also designs custom procedural kits and trays and provides OEM manufacturing, packaging, sterilization, and regulatory support. Its medical-device manufacturing is FDA registered and ISO 13485 certified, while its affiliated Long Island Sterilization operation has served customers since 2001 in a 30,000-square-foot facility.
ISO 13485
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FDA Registered Medical Device Manufacturer
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ISO 11135
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ISO 10993-7
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AAMI Sterilization Standards
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cGMP and FDA Guidelines
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