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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 (308)

Page 5 of 7

Device	Model / Reference	Registries	Class	Status
Silicone Penrose Drain Tube	2010-5419	FDA UDI	Class I	Active
Silicone Drainage Tube	60-100160	FDA UDI	Class I	Active
Silicone Endo Drain Kit (J Connector+Bendable Trocar)	2015-9610JB	FDA UDI	Class I	Active
Silicone Y Drainage Tube	1920-0016	FDA UDI	Class II	Active
Silicone 2-way Foley Balloon Catheter (Integrated Balloon)	4822-0516	FDA UDI	Class II	Active
Silicone Drainage Tube	70-025040	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)	1890-8212	FDA UDI	Class II	Active
Silicone Drainage Tube	65-013027	FDA UDI	Class I	Active
Silicone 2-way Foley Catheter Tiemann Tip (Standard Balloon)	1856-0224	FDA UDI	Class II	Active
Silicone Drainage Tube	65-050070	FDA UDI	Class I	Active
Silicone Hubless Endo Drain Kit	2015-9721	FDA UDI	Class I	Active
Silicone Flat Drain	2014-2072	FDA UDI	Class I	Active
Silicone Drainage Tube	60-095143	FDA UDI	Class I	Active
Silicone Drainage Tube	60-025040	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter (Ordinary Balloon)	1857-0214	FDA UDI	Class II	Active
Silicone Drainage Tube	40-036050	FDA UDI	Class I	Active
Silicone Flat Drain	2014-3102	FDA UDI	Class I	Active
Laryngeal Mask Tube	1580-0030	EUDAMEDFDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)	1890-8220	FDA UDI	Class II	Active
Silicone Drainage Tube	40-036048	FDA UDI	Class I	Active
Silicone Drainage Tube	40-040055	FDA UDI	Class I	Active
Silicone Thoracic Drain, RF Type	2018-0540	FDA UDI	Class I	Active
Silicone Thoracic Drain, SF Type	2018-0128	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter, Female (Standard Balloon)	1824-0512	FDA UDI	Class II	Active
Silicone Y Drainage Tube	1920-0022	FDA UDI	Class II	Active
Silicone 2-way Foley Balloon Catheter (Integrated Balloon)	4822-0524	FDA UDI	Class II	Active
Silicone Drainage Tube	40-040060	FDA UDI	Class I	Active
Silicone Drainage Tube	45-012025	FDA UDI	Class I	Active
Silicone Thoracic Drain, RF Type	2018-0532	FDA UDI	Class I	Active
Silicone Drainage Tube	40-012025	FDA UDI	Class I	Active
Silicone Round Drain	2015-0220	FDA UDI	Class I	Active
Silicone hubless Endo-drain (J Connector+Bendable Trocar)	2015-9715JB	FDA UDI	Class I	Active
Silicone Hubless Endo-Drain Tube+J connector	2015-0721J	FDA UDI	Class I	Active
Silicone Drainage Tube	40-050070	FDA UDI	Class I	Active
Silicone Supra-Pubic Catheter Puncture Set (Integrated Balloon)	4890-9212	EUDAMEDFDA UDI	Class II	Active
Silicone Drainage Tube	60-040055	FDA UDI	Class I	Active
Silicone Drainage Tube	65-100140	FDA UDI	Class I	Active
Silicone Endo-Drain Kit	2015-9615	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Standard Balloon)	1821-0610	FDA UDI	Class II	Active
Silicone Penrose Drain Tube	2010-1406	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0021	FDA UDI	Class I	Active
Silicone Round Drain Kit	2015-9318	FDA UDI	Class I	Active
Silicone Thoracic Drain, S Type	2018-0022	FDA UDI	Class I	Active
Silicone Vac-Drain Kit	2014-9415	FDA UDI	Class I	Active
Silicone Drainage Tube	45-025040	FDA UDI	Class I	Active
Silicone Vac-Drain Kit	2014-9408	FDA UDI	Class I	Active
Silicone Drainage Tube	60-030050	FDA UDI	Class I	Active
Silicone 2-way Foley Balloon Catheter (Standard Balloon)	1823-0524	FDA UDI	Class II	Active
Silicone Drainage Tube	60-070095	FDA UDI	Class I	Active
Silicone Drainage Tube	60-080120	FDA UDI	Class I	Active

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