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

Catalogue (310)

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Device	Model / Reference	Registries	Class	Status
Silicone Penrose Drain Tube	2010-5410	FDA UDI	Class I	Active
Silicone T Drainage Set	1910-8020	FDA UDI	Class II	Active
Silicone Drainage Tube	65-012025	FDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9314	FDA UDI	Class I	Active
Silicone Drainage Tube	60-060100	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip (Integrated Balloon)	4856-0224	FDA UDI	Class II	Active
Silicone Endo Drain Kit (J Connector+Bendable Trocar)	2015-9621JB	FDA UDI	Class I	Active
Silicone Drainage Tube	60-032064	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Standard Balloon)	1822-0526	FDA UDI	Class II	Active
Rystora® Scar Sheets	SA101801	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)	1890-8216	EUDAMEDFDA UDI	Class II	Active
Silicone Hubless Endo-Drain Tube+J connector	2015-0719J	FDA UDI	Class I	Active
Silicone Drainage Tube	45-014028	FDA UDI	Class I	Active
Silicone Hubless Endo-Drain Tube	2015-0721	FDA UDI	Class I	Active
Laryngeal Mask Tube	1580-0050	EUDAMEDFDA UDI	Class I	Active
Silicone Thoracic Drain, SF Type	2018-0136	FDA UDI	Class I	Active
Silicone Vac-Drain	2014-0408	FDA UDI	Class I	Active
Silicone Round Drain	2015-0316	FDA UDI	Class I	Active
Silicone Drainage Tube	45-050070	FDA UDI	Class I	Active
Silicone Round Drain	2015-0308	FDA UDI	Class I	Active
Silicone Drainage Tube	60-090120	FDA UDI	Class I	Active
Silicone Vac-Drain	2014-0411	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter (Integrated Balloon)	4890-0212	FDA UDI	Class II	Active
Silicone Endo Drain Kit (J Connector+Bendable Trocar)	2015-9615JB	FDA UDI	Class I	Active
Silicone Flat Drain Kit	2014-9101	FDA UDI	Class I	Active
Silicone C.W.V. Reservoir	2013-0910	FDA UDI	Class I	Active
Silicone Vac-Drain	2014-0419	FDA UDI	Class I	Active
Silicone Drainage Tube	60-070120	FDA UDI	Class I	Active
Silicone T Drainage Set With Eyes	1910-8216	FDA UDI	Class II	Active
Silicone C.W.V. Reservoir	2013-0640	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Standard Balloon)	1823-0526	FDA UDI	Class II	Active
Silicone Drainage Tube	60-005010	FDA UDI	Class I	Active
Silicone Thoracic Drain, RF Type	2018-0536	FDA UDI	Class I	Active
Silicone Drainage Tube	60-064111	FDA UDI	Class I	Active
Silicone Hubless Endo Drain Kit with Bendable Trocar	2015-9721B	FDA UDI	Class I	Active
Silicone Flat Drain Kit	2014-9071	FDA UDI	Class I	Active
Silicone Hubless Endo Drain Kit with Bendable Trocar	2015-9715B	FDA UDI	Class I	Active
Silicone Drainage Tube	60-036048	FDA UDI	Class I	Active
Silicone Penrose Drain Tube	2010-1415	FDA UDI	Class I	Active
Rystora Skin Protector-Spray	SY01030	EUDAMEDFDA UDI	Class I	Active
Silicone T Drainage Tube	1910-0014	FDA UDI	Class II	Active
Silicone Thoracic Drain, RF Type	2018-0524	FDA UDI	Class I	Active
Silicone Y Drainage Tube	1920-0018	FDA UDI	Class II	Active
Laryngeal Mask Tube	1580-0040	EUDAMEDFDA UDI	Class I	Active
Silicone Vac Drain Kit +J connector	2014-9410J	FDA UDI	Class I	Active
Silicone Drainage Tube	60-060120	FDA UDI	Class I	Active
Silicone Flat Drain Kit	2014-9132	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Grooved Balloon)	1827-0024	FDA UDI	Class II	Active
Silicone hubless Endo-drain (J Connector+Bendable Trocar)	2015-9710JB	FDA UDI	Class I	Active
Silicone Vac-Drain Kit	2014-9421	FDA UDI	Class I	Active

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