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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 5 of 9

Device	Model / Reference	Registries	Class	Status
Silicone 2-way Foley Balloon Catheter	Silicone 2-way Foley Balloon Catheter	EUDAMEDFDA UDI	Class IIb	Active
Silicone T Drainage Tube	1910-0016	EUDAMEDFDA UDI	Class IIa	Active
Silicone Gastrostomy Catheter with ENFit Connector	2019-0518	EUDAMED	Class IIb	Active
Silicone Gastrostomy Catheter	2019-0024	EUDAMED	Class IIb	Active
Silicone Hub-less Endo Drain Tube	2015-0724	EUDAMEDFDA UDI	Class IIa	Active
Silicone Tracheostomy Tube	1561-0070	EUDAMED	Class IIb	Active
Silicone Nasogastric Tube with ENFit Connector	2020-0506	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter, Female	1824-0514	EUDAMEDFDA UDI	Class IIb	Active
Silicone 3-way Foley Balloon Catheter, Female	1830-0524	EUDAMEDFDA UDI	Class IIb	Active
Silicone Penrose Straight Drain Tube	2011-0045	EUDAMEDFDA UDI	Class IIa	Active
Silicone Supra-Pubic Catheter	4890-0220	EUDAMEDFDA UDI	Class IIb	Active
Silicone Nephrostomy Catheter	1853-0218	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0005	EUDAMEDFDA UDI	Class IIa	Active
Silicone 3-way Hematuria Catheter	1861-0320	EUDAMED	Class IIb	Active
Sillcone Endotracheal Tube	1555-0070	EUDAMED	Class IIa	Active
Silicone Supra-Pubic Catheter	4890-0212	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1827-0018	EUDAMEDFDA UDI	Class IIb	Active
Silicone Gastric Tube with ENFit Connector	2020-0508	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6412	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter	1821-0510	EUDAMEDFDA UDI	Class IIb	Active
Silicone Penrose Drain Tube	2010-0410	EUDAMED	Class IIa	Active
Silicone Nasogastric Tube with ENFit Connector	2020-0518	EUDAMED	Class IIb	Active
Silicone 3-way Hematuria Catheter	1863-0320	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-5412	EUDAMED	Class IIa	Active
Silicone Stomach Tube	2020-0006	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	4822-0520	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	1856-0216	EUDAMEDFDA UDI	Class IIb	Active
Silicone Vac Drain, Round	CO2014-0410	EUDAMED	Class IIa	Active
Silicone T Drainage Tube With Eyes	1910-0218	EUDAMEDFDA UDI	Class IIa	Active
Catheter Spigot	1820 series	EUDAMED	Class I	Active
Silicone Stomach Tube	2020-0008	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1827-0022	EUDAMEDFDA UDI	Class IIb	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6405	EUDAMED	Class IIa	Active
Silicone Vac Drain, Flat	CO2014-0408	EUDAMED	Class IIa	Active
silicone 2-way Foley Cathrter	4833-0514	EUDAMED	Class IIb	Active
Silicone Nasal Epistaxis Balloon	3102-2010	EUDAMED	Class I	Active
Silicone Thoracic Drain, S Type	2018-0016	EUDAMEDFDA UDI	Class IIa	Active
Silicone Hematuria Catheter, Dufour	1864-0320	EUDAMED	Class IIb	Active
Silicone Nephrostomy Catheter	1853-0216	EUDAMED	Class IIb	Active
Silicone Endotracheal Tube	1555-0080	EUDAMED	Class IIa	Active
Silicone 3-way Hematuria Catheter	1862-0320	EUDAMED	Class IIb	Active
Silicone Supra-Pubic Catheter	A4880-0214	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6425	EUDAMEDFDA UDI	Class IIa	Active
Silicone Sump Drain Tube	2016-0214	EUDAMEDFDA UDI	Class IIa	Active
Silicone Birth Vac Cup	1300-0070	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6406	EUDAMEDFDA UDI	Class IIa	Active
Silicone Gastric Tube, Detachable Type	2020-5514	EUDAMED	Class IIb	Active
Silicone Round Drain Kit	2015-9220	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube	2010-0415	EUDAMEDFDA UDI	Class IIa	Active
Silicone Birth Vac Cup	1300-0060	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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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