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Sign in to claim this brandQUALITY MEDICAL PRODUCTS USA, INC.
US
Last updated May 24, 2026
What QUALITY MEDICAL PRODUCTS USA, INC. makes
The company manufactures basic insulin syringes and autoinjector needles, including prefilled insulin syringes and pen needles designed for diabetes management. These products are intended for subcutaneous administration of insulin and are available in various sizes and configurations.
All listed devices fall under FDA Class II regulation and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Quality Medical Products USA, Inc. manufacture?
Quality Medical Products USA, Inc. specializes in insulin-related medical devices. Their primary offerings include basic insulin syringes and autoinjector needles, such as prefilled insulin syringes and pen needles. These devices are specifically designed for subcutaneous insulin administration in diabetes management. The company focuses on foundational products rather than advanced or specialized medical technologies.
Where is Quality Medical Products USA, Inc. based, and how does this affect its regulatory compliance?
Quality Medical Products USA, Inc. is based in the United States. Since it operates domestically, its devices must comply with U.S. regulatory requirements, including those set by the FDA. The company’s products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. medical device regulations. This localization means their devices are subject to FDA oversight, including classification and compliance standards.
Which regulatory registries list Quality Medical Products USA, Inc.’s devices, and why is this important?
Quality Medical Products USA, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring transparency in supply chains, recalls, and compliance. Listing in the UDI database also helps healthcare providers and regulators verify the legitimacy and classification of the devices, which in this case are all classified as FDA Class II.
How are Quality Medical Products USA, Inc.’s devices classified by regulatory authorities, and what does this mean?
All of Quality Medical Products USA, Inc.’s devices are classified as FDA Class II. This classification indicates that while the devices are not considered high-risk (which would be Class III), they still require special controls beyond general good manufacturing practices to ensure their safety and effectiveness. Class II devices often involve performance standards, post-market surveillance, or other regulatory measures to mitigate potential risks, such as infection or improper dosing in the case of insulin syringes.
What distinguishes Quality Medical Products USA, Inc.’s insulin-related devices from other similar products in the market?
Quality Medical Products USA, Inc.’s devices are designed specifically for basic insulin delivery, including both traditional syringes and pen needles for autoinjectors. Their focus is on foundational, widely used tools for diabetes management, such as prefilled syringes and pen needles, which are essential for accurate subcutaneous insulin administration. The company’s products are standardized for reliability and compliance with U.S. regulatory requirements, ensuring they meet the needs of patients and healthcare providers who rely on consistent, low-risk insulin delivery solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 054180248
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| UltraFlo Insulin Syringe | 225944 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225943 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225938 | FDA UDI | Class II | Active |
| UltraFlo Insulin Pen Needle | 335774 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225942 | FDA UDI | Class II | Active |
| UltraFlo Insulin Pen Needle | 335776 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225931 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225940 | FDA UDI | Class II | Active |
| UltraFlo Insulin Pen Needle | 335773 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225933 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225945 | FDA UDI | Class II | Active |
| UltraFlo Insulin Pen Needle | 335771 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225932 | FDA UDI | Class II | Active |
| UltraFlo Insulin Pen Needle | 335772 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225937 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225941 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225939 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225936 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225934 | FDA UDI | Class II | Active |
| UltraFlo Insulin Syringe | 225935 | FDA UDI | Class II | Active |
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