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FORTUNE MEDICAL INSTRUMENT CORP.

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: —
Website: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 656763489

Catalogue (310)

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Device	Model / Reference	Registries	Class	Status
Silicone Thoracic Drain, SF Type	2018-0132	FDA UDI	Class I	Active
Silicone Vac-Drain	2014-0415	FDA UDI	Class I	Active
Silicone Drainage Tube	60-050070	FDA UDI	Class I	Active
Silicone Sump Drain Tube	2016-1220	FDA UDI	Class I	Active
Silicone Stomach Tube	2020-0005	FDA UDI	Class II	Active
Silicone Drainage Tube	60-020050	FDA UDI	Class I	Active
Silicone Thoracic Drain, RF Type	2018-0516	FDA UDI	Class I	Active
Silicone Vac Drain Kit +J connector	2014-9421J	FDA UDI	Class I	Active
Silicone Round Drain	2015-0310	FDA UDI	Class I	Active
Silicone Special Penrose Drain Tube	2012-0006	FDA UDI	Class I	Active
Silicone T Drainage Tube With Eyes	1910-0222	FDA UDI	Class II	Active
Silicone Drainage Tube	45-060080	FDA UDI	Class I	Active
Silicone Penrose Drain Tube	2010-5405	FDA UDI	Class I	Active
Silicone Endo Drain Kit with Bendable Trocar	2015-9621B	FDA UDI	Class I	Active
Silicone C.W.V. Reservoir	2013-0940	FDA UDI	Class I	Active
Silicone Vac-Drain	2014-0421	FDA UDI	Class I	Active
Silicone Round Drain	2015-0314	FDA UDI	Class I	Active
Silicone Drainage Tube	65-014028	FDA UDI	Class I	Active
Silicone Drainage Tube	60-090140	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)	1890-8218	FDA UDI	Class II	Active
Silicone Drainage Tube	65-060080	FDA UDI	Class I	Active
Silicone C.W.V. reservoir, 100 cc, bottom outlet	2013-091040	FDA UDI	Class I	Active
Silicone Endo Drain Kit with Bendable Trocar	2015-9615B	FDA UDI	Class I	Active
Rystora® Scar Sheets	SA042512	EUDAMEDFDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9320	FDA UDI	Class I	Active
Silicone Endo Drain Kit with Bendable Trocar	2015-9619B	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon)	4890-8216	FDA UDI	Class II	Active
Silicone Sump Drain Tube	2016-1320	FDA UDI	Class I	Active
Rystora® Scar Sheets	SA101812	FDA UDI	Class I	Active
Silicone Vac Drain Kit +J connector	2014-9411J	FDA UDI	Class I	Active
Silicone Y Drainage Tube	1920-0024	FDA UDI	Class II	Active
Silicone Endo-Drain Kit	2015-9621	FDA UDI	Class I	Active
Silicone Endo-Drain Kit	2015-9619	FDA UDI	Class I	Active
Silicone Drainage Tube	60-040080	FDA UDI	Class I	Active
Laryngeal Mask Tube	1580-0025	EUDAMEDFDA UDI	Class I	Active
Silicone Drainage Tube	40-060080	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0033	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter, Female (Standard Balloon)	1824-0516	FDA UDI	Class II	Active
Silicone C.W.V. reservoir, 400 cc, bottom outlet	2013-094080	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter (Ordinary Balloon)	1890-0222	FDA UDI	Class II	Active
Silicone Supra-Pubic Catheter (Ordinary Balloon)	1857-0216	FDA UDI	Class II	Active
Silicone Special Penrose Drain Tube	2012-0012	FDA UDI	Class I	Active
Silicone Flat Drain	2014-0051	FDA UDI	Class I	Active
Silicone Drainage Tube	60-060080	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0034	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0012	FDA UDI	Class I	Active
Silicone Drainage Tube	45-070095	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Standard Balloon)	1821-0608	FDA UDI	Class II	Active
Silicone Penrose Drain Tube	2010-5419	FDA UDI	Class I	Active
Silicone Drainage Tube	60-100160	FDA UDI	Class I	Active

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