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Sign in to claim this brandWhat DMC MEDICAL LIMITED makes
DMC Medical Limited manufactures metered-delivery hypodermic syringes and needles in various sizes and gauges, including retractable and insulin-specific designs. They also produce vein irrigation and distention sets, such as the Sapheneous Vein Distention System, used to dilate veins under controlled pressure. Cardiac insulation pads are part of their product range, designed for medical procedures requiring electrical isolation.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to applicable regulatory standards for medical devices.
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 DMC Medical Limited manufacture?
DMC Medical Limited specializes in metered-delivery hypodermic syringes and needles, including retractable and insulin-specific designs like the 1ml Insulin Suresafe Syringe and 3ml Suresafe Manual Retractable Syringe. They also produce vein irrigation and distention sets, such as the Sapheneous Vein Distention System (SVDS300), which is used to dilate veins under controlled pressure. Additionally, their product range includes cardiac insulation pads, which are designed for procedures requiring electrical isolation.
Where is DMC Medical Limited based, and what regulatory region do their devices serve?
DMC Medical Limited is based in the United States. Their devices are intended for use within this regulatory region, adhering to applicable FDA standards. The company’s products are classified under FDA regulations, ensuring compliance with U.S. medical device requirements.
Which regulatory registries or databases list DMC Medical Limited’s devices?
DMC Medical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices, ensuring transparency and traceability in the regulatory process. This listing applies to most of their products, including syringes, vein distention systems, and insulation pads.
How are DMC Medical Limited’s devices classified under FDA regulations?
DMC Medical Limited’s devices are classified under two main FDA categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
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
- 989772017
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3ml Suresafe Manual Retractable Syringe 25G x 1" | 3ml 25G x 1" | FDA UDI | Class II | Active |
| 1ml Insulin Suresafe Syringe | 1ml Insulin Syringe - 29G x 1/2" | FDA UDI | Class II | Active |
| 5ml Suresafe Syringe | 5ml Syringe - 22G x 1 1/2" | FDA UDI | Class II | Active |
| 5ml Suresafe Manual Retractable Syringe 22G x 1 1/2" | 5ml 22G x 1 1/2" | FDA UDI | Class II | Active |
| SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg | SVDS300 | FDA UDI | Class II | Active |
| 5ml Suresafe Syringe | 5ml Syringe - 21G x 1 1/2" | FDA UDI | Class II | Active |
| 1ml Insulin Suresafe Manual Retractable Syringe 29G x 1/2" | 1ml Insulin 29G x 1/2" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 22G x 1" | FDA UDI | Class II | Active |
| 10ml Suresafe Manual Retractable Syringe 21G x 1 1/2" | 10ml 21G x 1 1/2" | FDA UDI | Class II | Active |
| Suresafe 1ml Syringe | 1ml Syringe - 25G x 5/8" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 22G x 1 1/2" | FDA UDI | Class II | Active |
| 10ml Suresafe Syringe | 10ml Syringe - 21G x 1 1/2" | FDA UDI | Class II | Active |
| 10ml Suresafe Syringe | 10ml Syringe - 22G x 1 1/2" | FDA UDI | Class II | Active |
| Cardiac Insulation Pad Adult Sterile | Adult - Sterile | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 23G x 1" | FDA UDI | Class II | Active |
| 1ml Tuberculin Suresafe Syringe | 1ml Tuberculin Syringe - 25G x 1" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 21G x 1" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 23G x 1 1/2" | FDA UDI | Class II | Active |
| 1ml Suresafe Manual Retractable Syringe 25G x 1" | 1ml 25G x 1" | FDA UDI | Class II | Active |
| SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg | SVDS200 | FDA UDI | Class II | Active |
| Vein Irrigation Cannula DMC VIC Sterile | DMC VIC STERILE | FDA UDI | Class I | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 25G x 5/8" | FDA UDI | Class II | Active |
| 0.5ml Insulin - Suresafe Manual Retractable Syringe | 0.5ml Insulin 29G x 1/2" | FDA UDI | Class II | Active |
| 1ml Tuberculin Suresafe Syringe | 1ml Tuberculin Syringe - 25G x 5/8" | FDA UDI | Class II | Active |
| 1ml Tuberculin Suresafe Manual Retractable Syringe 27G x 1/2" | 1ml Tuberculin 27G x 1/2" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 25G x 1" | FDA UDI | Class II | Active |
| 3ml Suresafe Syringe | 3ml Syringe - 21G x 1 1/2" | FDA UDI | Class II | Active |
| 0.5ml Suresafe Syringe | 0.5ml Syringe 29G x 1/2" | FDA UDI | Class II | Active |
| 1ml Tuberculin Suresafe Syringe | 1ml Tuberculin Syringe - 27G x 1/2" | FDA UDI | Class II | Active |
| Suresafe 1ml Syringe | 1ml Syringe - 25G x 1" | FDA UDI | Class II | Active |
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