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FORTUNE MEDICAL INSTRUMENT CORP.

Taiwan·TW-MF-000009221

Last updated September 17, 2026

Information

Country: Taiwan
Address: 6F., No. 29, Sec. 2, Jhongjheng E. Rd., Danshuei Dist.,, New Taipei City, Taiwan
Website: fortunemed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Carson Chang
EUDAMED SRN: TW-MF-000009221
FDA FEI Number: 3006582718
DUNS Number: —

Catalogue (418)

Page 8 of 9

Device	Model / Reference	Registries	Class	Status
Silicone Penrose Drain Tube	2010-1410	EUDAMED	Class IIa	Active
Silicone Vessel ID Loops	9005-2510B	EUDAMED	Class IIa	Active
Silicone Nasogastric Tube with ENFit Connector	2020-0508	EUDAMED	Class IIb	Active
Silicone Gastrostomy Catheter	2019-0026	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0008	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube	2010-1412	EUDAMED	Class IIa	Active
Silicone Thoracic Drain, S Type	2018-0020	EUDAMEDFDA UDI	Class IIa	Active
Silicone Gastrostomy Catheter with ENFit Connector	2019-0516	EUDAMED	Class IIb	Active
SILICONE Foley Balloon Catheter	65 20 20	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	4822-0516	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	1856-0222	EUDAMED	Class IIb	Active
Slllcone Tracheostomy Tube, Ordinary Cuff	1560-0070	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1822-0514	EUDAMEDFDA UDI	Class IIb	Active
Silicone Thoracic Drain, RF Type	2018-0520	EUDAMED	Class IIa	Active
Silicone Thoracic Drain, S Type	2018-0027	EUDAMED	Class IIa	Active
Silicone 2-way Foley Balloon Catheter	4833-0518	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1822-0520	EUDAMEDFDA UDI	Class IIb	Active
Silicone T Drainage Tube With Eyes	1910-0210	EUDAMEDFDA UDI	Class IIa	Active
Silicone Flat Drain	CO2014-0072	EUDAMED	Class IIa	Active
Silicone T Drainage Tube	1910-0012	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube	1910-0010	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube With Eyes	1910-0224	EUDAMEDFDA UDI	Class IIa	Active
Silicone Vac Drain, Flat	CO2014-0411	EUDAMED	Class IIa	Active
Silicone Round Drain Tube	CO2015-0218	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6419	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube With Eyes	1910-0224	EUDAMED	Class IIa	Active
Silicone Nephrostomy Catheter	1853-0208	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0220	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter, Female	1827-0020	EUDAMED	Class IIb	Active
Silicone Stomach Tube	2020-0006	EUDAMEDFDA UDI	Class IIb	Active
Silicone Thoracic Drain, RF Type	2018-0528	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter	1823-0520	EUDAMEDFDA UDI	Class IIb	Active
Silicone Supra-Pubic Catheter	4880-0216	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1827-0020	EUDAMEDFDA UDI	Class IIb	Active
Silicone Endo Drain	2015-0621	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube With Eyes	1910-0214	EUDAMED	Class IIa	Active
Silicone 3-way Hematuria Catheter	1861-0322	EUDAMED	Class IIb	Active
Silicone 3-way Foley Balloon Catheter	1830-0516	EUDAMEDFDA UDI	Class IIb	Active
silicone 2-way Foley Cathrter	4833-0518	EUDAMED	Class IIb	Active
Silicone Hematuria Catheter, Dufour	1864-0322	EUDAMED	Class IIb	Active
Silicone Sump Drain Tube	2016-0220	EUDAMED	Class IIa	Active
Silicone Hematuria Catheter, Couvelaire	1865-0322	EUDAMED	Class IIb	Active
Silicone Thoracic Drain, S Type	2018-0020	EUDAMED	Class IIa	Active
Silicone 3-way Foley Balloon Catheter	1830-0522	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1822-0522	EUDAMED	Class IIb	Active
Silicone Hematuria Catheter, Couvelaire	1865-0322	EUDAMED	Class IIb	Active
Silicone Endo Drain	2015-0615	EUDAMEDFDA UDI	Class IIa	Active
Silicone Supra-Pubic Catheter	4890-0218	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0222	EUDAMEDFDA UDI	Class IIb	Active
Silicone Round Drain Tube	CO2015-0210	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Fortune Medical Instrument Corp. US