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LELTEK INC.

Taiwan·TW-MF-000013923

Last updated September 17, 2026

Information

Country: Taiwan
Address: 6F-3, No.293, , Sec.1, Beixin Rd., Xindian Dist.,, New Taipei City, Taiwan
Website: www.leltek.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +886-2-2913-7577
PRRC Contact: Paul Chang
EUDAMED SRN: TW-MF-000013923
FDA FEI Number: 3014555455
DUNS Number: 656116467

Catalogue (14)

Device	Model / Reference	Registries	Class	Status
Norland at Swissray	LU700C	FDA UDI	Class II	Active
LeSono	LU700L	FDA UDI	Class II	Active
Norland at Swissray	LU700L	FDA UDI	Class II	Active
Leltek	LU710M	FDA UDI	Class II	Active
LeSono	LU700C	FDA UDI	Class II	Active
LeSono	LU700	FDA UDI	Class II	Unknown
Asus	LU700C / LU700L	EUDAMEDFDA UDI	Class IIa	Active
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging	K241161	FDA 510(k)	Class II	Active
LELTEK Ultrasound Imaging System (Model: LU700 Series)	K210432	FDA 510(k)	Class II	Active
Leltek Ultrasound Imaging System	K191235	FDA 510(k)	Class II	Active
Leltek Ultrasound Imaging System (Model: LU700 Series)	K222365	FDA 510(k)	Class II	Active
Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)	K243226	FDA 510(k)	Class II	Active
Asus	LU700C	EUDAMEDFDA UDI	Class IIa	Active
Leltek	LU700C/LU700L	EUDAMED	Class IIa	Active

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