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Sign in to claim this brandFORTUNE MEDICAL INSTRUMENT CORP.
US
Last updated May 29, 2026
Part of Fortune Medical Instrument Corp.
What FORTUNE MEDICAL INSTRUMENT CORP. makes
The company manufactures silicone-based drainage devices, including closed-wound drains like flat drains and capillary luminal drains, as well as single-use suction/irrigation tubing. Their portfolio also covers urinary drainage solutions such as indwelling urethral balloon catheters and suprapubic drainage catheters, alongside pleural and biliary drainage systems. Additional products include centesis drainage receptacles and specialized kits for endoscopic drainage procedures.
These devices are regulated under the FDA’s Class I and Class II categories, with most listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates within the United States, adhering to applicable medical device regulations for drainage and catheter products.
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 Fortune Medical Instrument Corp. manufacture?
Fortune Medical Instrument Corp. specializes in silicone-based drainage devices. Their portfolio includes closed-wound drains (such as flat drains and capillary luminal drains), single-use suction/irrigation tubing, urinary drainage solutions (including indwelling urethral balloon catheters and suprapubic drainage catheters), pleural and biliary drainage systems, and centesis drainage receptacles. They also produce specialized kits for endoscopic drainage procedures.
Where is Fortune Medical Instrument Corp. based?
Fortune Medical Instrument Corp. is based in the United States. As a manufacturer, they operate within the country’s regulatory framework for medical devices, ensuring compliance with applicable standards for drainage and catheter products.
Which regulatory registries list Fortune Medical Instrument Corp.’s devices?
Fortune Medical Instrument Corp.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify their products, including silicone drainage tubes, catheters, and specialized drainage kits, under the FDA’s regulatory oversight.
How are Fortune Medical Instrument Corp.’s devices classified under FDA regulations?
Fortune Medical Instrument Corp.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
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
- 656763489
Catalogue (310)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Laryngeal Mask Tube | 1580-0015 | EUDAMEDFDA UDI | Class I | Active |
| Silicone C.W.V. Reservoir (Top Outlet) | 2013-1640 | FDA UDI | Class I | Active |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | 1857-0212 | FDA UDI | Class II | Active |
| Rystora® Scar Sheets | SA050701 | FDA UDI | Class I | Active |
| Silicone Flat Drain Kit | 2014-9072 | EUDAMEDFDA UDI | Class I | Active |
| Silicone Vac-Drain Kit | 2014-9419 | FDA UDI | Class I | Active |
| Silicone Flat Drain Kit | 2014-9131 | FDA UDI | Class I | Active |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | 1890-0214 | FDA UDI | Class II | Active |
| Silicone Hubless Endo Drain Kit (J Connector+Trocar) | 2015-9710J | EUDAMEDFDA UDI | Class I | Active |
| Silicone T Drainage Set With Eyes | 1910-8212 | EUDAMEDFDA UDI | Class II | Active |
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