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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 3 of 9

Device	Model / Reference	Registries	Class	Status
Silicone Sump Drain Tube	2016-0320	EUDAMED	Class IIa	Active
Silicone T Drainage Tube With Eyes	1910-0212	EUDAMEDFDA UDI	Class IIa	Active
Silicone Vessel ID Loops	9005-0503B	EUDAMED	Class IIa	Active
Silicone Gastric Tube, Detachable Type	2020-6014	EUDAMED	Class IIb	Active
Silicone Vessel ID Loops	9005-5013Y	EUDAMED	Class IIa	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0212	EUDAMEDFDA UDI	Class IIb	Active
Silicone Penrose Drain Tube	2010-1425	EUDAMEDFDA UDI	Class IIa	Active
Silicone T Drainage Tube	1910-0016	EUDAMED	Class IIa	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	4856-0216	EUDAMEDFDA UDI	Class IIb	Active
Silicone 2-way Foley Balloon Catheter, Female	1824-0514	EUDAMED	Class IIb	Active
Silicone 3-way Hematuria Catheter	1863-0324	EUDAMED	Class IIb	Active
Silicone Stomach Tube	2020-0010	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0008	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube	2010-0410	EUDAMED	Class IIa	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0090	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-5408	EUDAMEDFDA UDI	Class IIa	Active
Silicone 3-way Hematuria Catheter	1861-0324	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0024	EUDAMEDFDA UDI	Class IIa	Active
Silicone 3-way Hematuria Catheter	1862-0324	EUDAMED	Class IIb	Active
Silicone Hematuria Catheter, Couvelaire	1865-0318	EUDAMED	Class IIb	Active
Silicone Sump Drain Tube	2016-0120	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube	2010-0412	EUDAMEDFDA UDI	Class IIa	Active
Silicone Penrose Drain Tube	2010-1408	EUDAMEDFDA UDI	Class IIa	Active
Silicone Round Drain	2015-0208	EUDAMEDFDA UDI	Class IIa	Active
Silicone Nasal Epistaxis Balloon	3102-2010	EUDAMEDFDA UDI	Class I	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-5412	EUDAMED	Class IIa	Active
Silicone Sump Drain Tube	2016-0220	EUDAMEDFDA UDI	Class IIa	Active
Silicone Vessel ID Loops	9005-5013Y	EUDAMED	Class IIa	Active
Silicone 3-way Hematuria Catheter	1861-0320	EUDAMED	Class IIb	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	1856-0212	EUDAMED	Class IIb	Active
Silicone T Drainage Tube With Eyes	1910-0220	EUDAMED	Class IIa	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0060	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0012	EUDAMED	Class IIa	Active
Silicone T Drainage Tube	1910-0024	EUDAMED	Class IIa	Active
Silicone T Drainage Tube	1910-0020	EUDAMEDFDA UDI	Class IIa	Active
Silicone Thoracic Drain, RF Type	2018-0520	EUDAMEDFDA UDI	Class IIa	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0085	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube	2010-0410	EUDAMEDFDA UDI	Class IIa	Active
Silicone 2-way Foley Balloon Catheter Tiemann Tip	1856-0210	EUDAMEDFDA UDI	Class IIb	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0100	EUDAMED	Class IIb	Active
Silicone T Drainage Tube	1910-0018	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-6406	EUDAMEDFDA UDI	Class IIa	Active
Silicone Gastric Tube, Detachable Type	2020-7016	EUDAMED	Class IIb	Active
Silicone Penrose Drain Tube	2010-1419	EUDAMEDFDA UDI	Class IIa	Active
Silicone Flat Drain	2014-0102	EUDAMED	Class IIa	Active
Silicone Flat Drain	PR2014-0101	EUDAMED	Class IIa	Active
Silicone Penrose Drain Tube W/ Secure-Clip	2010-5412	EUDAMEDFDA UDI	Class IIa	Active
Silicone Stomach Tube	2020-0016	EUDAMEDFDA UDI	Class IIb	Active
A0601010403	2015-0619	EUDAMEDFDA UDI	Class IIa	Active
Silicone Tracheostomy Tube, Low Pressure Cuff	1565-0095	EUDAMED	Class IIb	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