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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 4 of 9

Device	Model / Reference	Registries	Class	Status
Silicone Penrose Drain Tube	2010-0405	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6410	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube	2010-1412	EUDAMEDFDA UDI	Class IIa	Active
Silicone Thoracic Drain, SF Type	2018-0124	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube	2010-0406	EUDAMEDFDA UDI	Class IIa	Active
Silicone 3-way Foley Balloon Catheter, Female	1830-0514	EUDAMEDFDA UDI	Class IIb	Active
Silicone Thoracic Drain, S Type	2018-0028	EUDAMEDFDA UDI	Class IIa	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0075	EUDAMED	Class IIb	Active
Silicone Gastrostomy Catheter	2019-0024	EUDAMED	Class IIb	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0065	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter, Female	1827-0018	EUDAMED	Class IIb	Active
Silicone Stomach Tube	2020-0020	EUDAMED	Class IIb	Active
Silicone Nephrostomy Catheter	4853-0216	EUDAMED	Class IIb	Active
Silicone 3-way Hematuria Catheter	1863-0318	EUDAMED	Class IIb	Active
Silicone Endo Drain	2015-0621	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0218	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0214	EUDAMED	Class IIb	Active
Silicone Hub-less Endo Drain Tube	2015-0729	EUDAMEDFDA UDI	Class IIa	Active
Silicone Gastric Tube, Detachable Type	2020-5514	EUDAMED	Class IIb	Active
Silicone Thoracic Drain, S Type	2018-0027	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	1856-0214	EUDAMEDFDA UDI	Class IIb	Active
Silicone Thoracic Drain, S Type	2018-0024	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube	2010-1410	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube	1910-0022	EUDAMEDFDA UDI	Class IIa	Active
Silicone 3-way Hematuria Catheter	1861-0318	EUDAMED	Class IIb	Active
Silicone Hub-less Endo Drain Tube	2015-0715	EUDAMEDFDA UDI	Class IIa	Active
Silicone Round Drain Kit	2015-9220	EUDAMEDFDA UDI	Class IIa	Active
Silicone Sump Drain Tube	2016-0314	EUDAMEDFDA UDI	Class IIa	Active
Slllcone Tracheostomy Tube, Ordinary Cuff	1560-0090	EUDAMED	Class IIb	Active
1821-0606	Silicone 2-way Foley Balloon Catheter	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube	2010-0419	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6415	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter, Female	1827-0022	EUDAMED	Class IIb	Active
Silicone Tracheostomy Tube, Ordinary Cuff	1560-0080	EUDAMED	Class IIb	Active
Silicone Stomach Tube	2020-0018	EUDAMEDFDA UDI	Class IIb	Active
All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865	K021142	FDA 510(k)	Class II	Active
Fortune Silicone Vacuum Suction, Model #1300	K021193	FDA 510(k)	Class II	Active
All Silicone Supra-Pubia Catheter, Models 4880/4890	K014002	FDA 510(k)	Class II	Active
All Silicone 2-Way & 3-Way Foly Balloon Catheter And Nelaton Catheter	K980919	FDA 510(k)	Class II	Active
Fortune All Silicone Stomach (gastric) Tubes, Model 2020	K022112	FDA 510(k)	Class II	Active
All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes And Cwv Reservoir	K980917	FDA 510(k)	Class II	Active
Slllcone Tracheostomy Tube, Ordinary Cuff	1560-0080	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube	2010-0419	EUDAMED	Class IIa	Active
Silicone Tracheostomy Tube, Ordinary Cuff	1560-0070	EUDAMED	Class IIb	Active
Silicone 3-way Foley Balloon Catheter, Female	1830-0518	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter, Female	1827-0014	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	4822-0522	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter	1822-0518	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-Way Foley Balloon Catheter	1827-0014	EUDAMEDFDA UDI	Class IIb	Active
Silicone Thoracic Drain, SF Type	2018-0124	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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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