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Sign in to claim this brandPromisemed Medical Devices Inc.
US
Last updated May 23, 2026
What Promisemed Medical Devices Inc. makes
Promisemed Medical Devices Inc. manufactures single-use autoinjector needles, insulin syringes and needles, blood lancets, and sharps containers. Their product line includes devices designed for diabetic blood glucose monitoring and insulin delivery, as well as safety solutions for medical waste disposal.
All listed devices fall under FDA Class II regulation and are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 Promisemed Medical Devices Inc. manufacture?
Promisemed Medical Devices Inc. specializes in single-use medical devices primarily used in diabetes management and general healthcare. Their product line includes autoinjector needles, insulin syringes and needles, blood lancets for glucose monitoring, and sharps containers for safe disposal of used needles and sharps. These devices are designed to improve convenience, safety, and accuracy in medical procedures.
Where is Promisemed Medical Devices Inc. based, and what does that mean for their regulatory compliance?
Promisemed Medical Devices Inc. is based in the United States. Since they operate within the U.S., their devices must comply with U.S. medical device regulations, including registration with the FDA and adherence to applicable standards for safety, performance, and labeling. The company’s location ensures alignment with FDA requirements, which govern the design, manufacturing, and distribution of their products.
Which regulatory registries list Promisemed Medical Devices Inc.’s devices?
Promisemed Medical Devices Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory oversight. This registration is required for Class II devices, which include their autoinjector needles, insulin syringes, blood lancets, and sharps containers.
How are Promisemed Medical Devices Inc.’s devices classified by regulatory authorities?
All of Promisemed Medical Devices Inc.’s listed devices fall under FDA Class II classification. Class II devices are those that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to their autoinjector needles, insulin syringes, blood lancets, and sharps containers, reflecting the need for regulated manufacturing and compliance with specific performance standards.
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
- 114566189
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Verifine | IPN-33-04 | FDA UDI | Class II | Active |
| Verifine | ISY-8033108-100 | FDA UDI | Class II | Active |
| Verifine | IPN-31-06 | FDA UDI | Class II | Active |
| Verifine | ISY-8053108-100 | FDA UDI | Class II | Active |
| Verifine | NPN-31-08 | FDA UDI | Class II | Active |
| Verifine | IPN-29-12 | FDA UDI | Class II | Active |
| Verifine | ISY-8052912-100 | FDA UDI | Class II | Active |
| Verifine | ISY-7053008-100 | FDA UDI | Class II | Active |
| Verifine | IPN-32-05 | FDA UDI | Class II | Active |
| Verifine | IPN-31-04 | FDA UDI | Class II | Active |
| Verifine | SL-3018T | FDA UDI | Class II | Active |
| Verifine | ISY-7033108-100 | FDA UDI | Class II | Active |
| Verifine | SL-3018M | FDA UDI | Class II | Active |
| Verifine | IPN-32-04 | FDA UDI | Class II | Active |
| Verifine | BL-32G | FDA UDI | Class II | Active |
| Verifine | ISY-8102912-100 | FDA UDI | Class II | Active |
| Verifine | IPN-32-06 | FDA UDI | Class II | Active |
| Verifine | NPN-32-04 | FDA UDI | Class II | Active |
| Verifine | SL-2118M | FDA UDI | Class II | Active |
| Verifine | BL-33G | FDA UDI | Class II | Active |
| Verifine | NPN-31-06 | FDA UDI | Class II | Active |
| Verifine | BL-30G | FDA UDI | Class II | Active |
| Verifine | IPN-31-05 | FDA UDI | Class II | Active |
| Verifine | ISY-8103108-100 | FDA UDI | Class II | Active |
| Verifine | SL-2124M | FDA UDI | Class II | Active |
| Verifine | SSC-005 | FDA UDI | Class II | Active |
| Verifine | BL-28G | FDA UDI | Class II | Active |
| Verifine | IPN-31-08 | FDA UDI | Class II | Active |
| Verifine | ISY-7103106-100 | FDA UDI | Class II | Active |
| Verifine | ISY-8033106-100 | FDA UDI | Class II | Active |
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