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i-SENS, Inc.

South Korea·KR-MF-000009173

Last updated September 17, 2026

Information

Country: South Korea
Address: 43, Banpo-daero 28-gil, Seocho-gu, Seoul, South Korea
Website: i-sens.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 855-646-3231
PRRC Contact: Jeong Hwa Lee
EUDAMED SRN: KR-MF-000009173
FDA FEI Number: 3005621222
DUNS Number: 688840958

Catalogue (108)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
OneTouch Vita™ Receiver	CGM-R-004	EUDAMED	Class IIb	Active
CareSens Air Receiver	CGM-R-001	EUDAMED	Class IIb	Active
ALLYpro	HS-FE-51	EUDAMED	Class IIb	Active
OneTouch ShareVue™	HS-MA-06, HS-WA-14	EUDAMED	Class IIb	Active
CareSens Air Receiver	CGM-R-001	EUDAMED	Class IIb	Active
ALLYcgm Continuous Glucose Monitoring System	CGM-ST-004	EUDAMED	Class IIb	Active
CareSens Air Receiver	CGM-R-001	EUDAMED	Class IIb	Active
i-Smart 300 Cartridge	POCBGCT001-200T3W	EUDAMED	Class C	Active
CareSens Air Continuous Glucose Monitoring System	CGM-ST-002	EUDAMED	Class IIb	Active
CareSens Air Continuous Glucose Monitoring System	CGM-ST-002	EUDAMED	Class IIb	Active
OneTouch ShareVue™	HS-MI-06, HS-WI-14	EUDAMED	Class IIb	Active
ALLYpro	HS-MI-05, HS-WI-13	EUDAMED	Class IIb	Active
CareSens Air Continuous Glucose Monitoring System	CGM-ST-002	EUDAMED	Class IIb	Active
CareSens Air Receiver	CGM-R-001	EUDAMED	Class IIb	Active
Sens365	HS-MI-01, HS-WI-11	EUDAMED	Class IIb	Active
OneTouch Vita™ Receiver	CGM-R-004	EUDAMED	Class IIb	Active
ALLYpro	HS-MA-05, HS-WA-13	EUDAMED	Class IIb	Active
ALLYcgm Receiver	CGM-R-003	EUDAMED	Class IIb	Active
CareSens Air Receiver	CGM-R-001	EUDAMED	Class IIb	Active
Tempo	343004	FDA UDI	Class II	Active
Tempo	343262	FDA UDI	Class II	Active
KetoSens	276156	FDA UDI	Class I	Active
Fifty50	163140	FDA UDI	Class II	Active
Tempo	PGUHA-0000033	FDA UDI	Class II	Active
CareSens	PGUHA-0000002	FDA UDI	Class II	Active
KetoSens	276154	FDA UDI	Class I	Active
CareSens N Plus BT	164372	FDA UDI	Class II	Active
Fifty50	163308-302	FDA UDI	Class II	Active
KetoSens	276151	FDA UDI	Class I	Active
CareSens N Feliz BT	164508	FDA UDI	Class II	Active
CareSens N	164105	FDA UDI	Class II	Active
CareSoft	164006	FDA UDI	Class II	Active
Fifty50 Sport	163424-201	FDA UDI	Class II	Active
Cool	520001	FDA UDI	Class II	Active
CareSens S Fit	164506	FDA UDI	Class II	Active
KetoSens	276265	FDA UDI	Class I	Active
CareSens	PGUHA-0000003	FDA UDI	Class II	Active
CareSens N	164284	FDA UDI	Class II	Active
CareSens N (MedPoint Diagnostics)	155300-201	FDA UDI	Class II	Active
CareSens N Feliz	164503	FDA UDI	Class II	Active
KetoSens	276150	FDA UDI	Class I	Active
Tempo	343105	FDA UDI	Class II	Active
KetoSens	276262	FDA UDI	Class I	Active
CareSens N	164303-201	FDA UDI	Class II	Active
VeraSens Voice	282104-201	FDA UDI	Class II	Active
CareSens	PGUHA-0000060	FDA UDI	Class II	Active
Tempo	343104	FDA UDI	Class II	Active
Tempo	343264	FDA UDI	Class II	Active
KetoSens	276153-206	FDA UDI	Class I	Active
CareSens N	164307	FDA UDI	Class II	Active

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Medical Technology Promedt Consulting GmbH DE

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