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Taewoong Medical Co., Ltd.

South Korea·KR-MF-000007515

Last updated September 18, 2026

About

Taewoong Medical. A worldwide leading medical device company for minimally-invasive procedures.

From the manufacturer's own website, in their original language. Source

Information

Country: South Korea
Address: 14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, South Korea
Website: www.taewoongmedical.com/in/
LinkedIn: linkedin.com/company/taewoongmedical
Facebook: facebook.com/taewoongmedical
Email: [email protected]
Phone: +82 31 996 0641
PRRC Contact: Yongjin Kim
EUDAMED SRN: KR-MF-000007515
FDA FEI Number: —
DUNS Number: —

Catalogue (1289)

Page 25 of 26

Device	Model / Reference	Registries	Class	Status
Niti-S Stent & Introducer, Model Eoxxxx	K041648	FDA 510(k)	Class II	Active
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent	K250663	FDA 510(k)	Class II	Active
Niti-S Biliary Slim M Stent	K221071	FDA 510(k)	Class II	Active
Optimos™ Cystotome	K223256	FDA 510(k)	Class II	Active
Niti-S Biliary Speed D Stent	K223626	FDA 510(k)	Class II	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0805	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0605	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0806-6	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0809	EUDAMEDFDA UDI	Class IIb	Active
Optimos™ Guidewire	GW3-45A	EUDAMED	Class IIa	Active
Niti-S Biliary Uncovered Stent [S-Type]	B0606	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0812	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T0605	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T1012	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD1006	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD1012	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0804	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T1009	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0610	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0612	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T0610	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN1005	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD1009	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD1008	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0609	EUDAMED	Class IIb	Active
Optimos™ Guidewire	GW2-26S	EUDAMED	Class IIa	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0810	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	B0805	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD1009	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T0808	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0807	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	B0612	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T1004	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T0612	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0812	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD1010	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0604-6	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	T0604	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0805	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0804	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0609	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0808	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	B0809	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	BD0809	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0805-6	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0607-6	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [M-Type]	TN0610-6	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0605	EUDAMED	Class IIb	Active
Niti-S Biliary Uncovered Stent [D-Type]	TD0806	EUDAMEDFDA UDI	Class IIb	Active
Niti-S Biliary Uncovered Stent [S-Type]	B0605	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Taewoong Medical US