9001-2030 Québec Inc

9001-2030 Québec Inc produces three primary types of medical devices: disposable vacuum tubing for medical use, multi-parameter device testers designed to evaluate the performance of medical equipment, and single-use monopolar electrosurgical handpieces and electrodes intended for open-surgery procedures. These products are developed to meet specific clinical needs in surgical and diagnostic settings.

The company is headquartered in the United States. While the name includes 'Québec,' this appears to be part of the company’s identifier rather than its physical location, as the country listed is the US.

Devices produced by 9001-2030 Québec Inc are listed in the FDA’s Unique Device Identifier (UDI) database. This registry includes product identifiers for Class II devices, ensuring traceability and compliance with U.S. regulatory requirements.

All devices manufactured by 9001-2030 Québec Inc fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

The variations in device names—such as 'Jac-cell Medic' and 'Jac-cell Medic Inc.'—likely reflect different product iterations, branding adjustments, or regulatory filings. These distinctions may arise from updates to the device’s design, manufacturer details, or compliance requirements, ensuring each entry in the UDI database accurately reflects the specific product variant in use.