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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 1 of 9

Device	Model / Reference	Registries	Class	Status
Rystora® Silicone Scar Sheet (Non-Sterile)	SA050712	EUDAMED	Class I	Active
Silicone Mask	1611-9001	EUDAMED	Class IIa	Active
Silicone Mask	1611-9000	EUDAMED	Class IIa	Active
"Fortune" Laryngeal Mask Tube (Non-Sterile)	1580-0050	EUDAMED	Class IIa	Active
silicone Clamp Jaw Cover	9002-SR250	EUDAMED	Class I	Active
Silicone Vac Drain Kit, Round	PR2114-9405	EUDAMED	Class IIa	Active
Silicone Vac-Drain Kit, Round	CO2014-9419	EUDAMED	Class IIa	Active
silicone Clamp Jaw Cover	9002-LB570	EUDAMED	Class I	Active
Silicone Vac Drain Kit, Round	2014-9410	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9002	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9001	EUDAMED	Class IIa	Active
Silicone Vac-Drain Kit, Round	CO2014-9419	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9005	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9002	EUDAMED	Class IIa	Active
Silicone Mask	1611-9002	EUDAMED	Class IIa	Active
Silicone Mask	1611-9000	EUDAMED	Class IIa	Active
Silicone Mask	1611-9000	EUDAMED	Class IIa	Active
"Fortune" Laryngeal Mask Tube (Non-Sterile)	1580-0040	EUDAMED	Class IIa	Active
Silicone Mask	1611-9000	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9003	EUDAMED	Class IIa	Active
Rystora Adhesive Remover-Spray (Non-Sterile)	SR-085	EUDAMED	Class I	Active
Rystora® Silicone Scar Sheet (Non-Sterile)	SA042501	EUDAMED	Class I	Active
Air-Cush Mask	1691-9003	EUDAMED	Class IIa	Active
Silicone Vac Drain Kit, Round	PR2114-9403	EUDAMED	Class IIa	Active
Guedel Airway	1603-0090	EUDAMED	Class I	Active
Urinary Catheter Fixation Strap	1800-0002	EUDAMED	Class I	Active
Urinary Catheter Fixation Strap	1800-0002	EUDAMED	Class I	Active
Silicone Round Drain System	0915-921840	EUDAMED	Class IIa	Active
Urinary Catheter Fixation Strap	1800-0001	EUDAMED	Class I	Active
Air-Cush Mask	1691-9004	EUDAMED	Class IIa	Active
Silicone Vac-Drain Kit, Round	CO2014-9410	EUDAMED	Class IIa	Active
Silicone Vac Drain Bag System, Round	PR0940-940580	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9001	EUDAMED	Class IIa	Active
Silicone Vac-Drain Kit, Round	CO2014-9415	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9003	EUDAMED	Class IIa	Active
Silicone Mask	1611-9002	EUDAMED	Class IIa	Active
Silicone Clamp Jaw Cover	9002-SR250	EUDAMED	Class I	Active
Silicone Mask	1611-9003	EUDAMED	Class IIa	Active
PVC Resuscitator	1690-0002	EUDAMED	Class IIa	Active
Silicone Mask	1611-9002	EUDAMED	Class IIa	Active
Silicone Vac-Drain Kit, Round	CO2014-9419	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9005	EUDAMED	Class IIa	Active
Silicone Mask	1611-9004	EUDAMED	Class IIa	Active
Silicone Mask	1611-9005	EUDAMED	Class IIa	Active
Silicone Resuscitator	1610-0003	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9005	EUDAMED	Class IIa	Active
Guedel Airway	1603-0090	EUDAMED	Class I	Active
Silicone Vac Drain Bag System, Round	PR0940-940580	EUDAMED	Class IIa	Active
Air-Cush Mask	1691-9004	EUDAMED	Class IIa	Active
PVC Resuscitator	1690-0001	EUDAMED	Class IIa	Active

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Authorised Representatives

Emergo Europe B.V. NL

Importers

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Notified Bodies

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Authorities

Not available yet.

FDA Establishments (1)

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

Fortune Medical Instrument Corp. US