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Edan Instruments,Inc.

China·CN-MF-000009957

Last updated June 8, 2026

Information

Country: China
Address: 15, Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District , Shenzhen, China
Website: edan.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yongying Liu
EUDAMED SRN: CN-MF-000009957
FDA FEI Number: —
DUNS Number: —

Catalogue (547)

Page 3 of 11

Device	Model / Reference	Registries	Class	Status
Test Cartridge	iBG4	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
ECG Cable	EL05DISY1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03DIS061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC022	EUDAMEDFDA UDI	Class I	Active
Connection Cable	01.57.471028	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC004	EUDAMED	Class I	Active
ECG Cable	EL10NIGS1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03DAS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03EIS061	EUDAMEDFDA UDI	Class I	Active
Connection Cable	SHEC3	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC013	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BC4	EUDAMED	IVD General	Active
ECG Cable	iT30-EL3DACHO1	EUDAMED	Class I	Active
ECG Cable	ET03EGS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL05DAGY1	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	iBG3	EUDAMED	IVD General	Active
ECG Cable	RPAYACC004	EUDAMEDFDA UDI	Class I	Active
Lyse	HL310	EUDAMED	Class A	Active
ECG Cable	RPAYACC019	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC028	EUDAMEDFDA UDI	Class I	Active
Connection Cable	C04P0001	EUDAMEDFDA UDI	Class I	Active
Trolley (for medical use)	MT-206	EUDAMED	Class I	Active
ECG Cable	RPAYACC027	EUDAMEDFDA UDI	Class I	Active
Lyse	HL92N	EUDAMED	Class A	Active
ECG Cable	EC03EAG121	EUDAMEDFDA UDI	Class I	Active
Connection Cable	SHEC2	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC002	EUDAMED	Class I	Active
ECG Cable	EL06DISS1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC001	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC05EIG121	EUDAMEDFDA UDI	Class I	Active
Connection Cable	01.57.472179	EUDAMED	Class I	Active
ECG Cable	iT30-EL5DISHO1	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG3	EUDAMED	IVD General	Active
ECG Cable	EL05NIGS2	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
ECG Cable	ET05DGS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET03EGS062	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL03NISS1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC017	EUDAMEDFDA UDI	Class I	Active
ECG Cable	DECG-IK	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Patient Monitor (iX10, iX12, iX15)	K232962	FDA 510(k)	Class II	Active
Fetal & Maternal Monitor, Model F6, F9	K082602	FDA 510(k)	Class II	Active
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express	K150901	FDA 510(k)	Class II	Active
Sonotrax Ultrasonic Fetal And Vascular Pocket Doppler, Models Lite, Basic, Pro, Ii, Ii Pro And Vascular	K080087	FDA 510(k)	Class II	Active
Fetal Maternal Monitor Model F9 Express And Express	K100797	FDA 510(k)	Class II	Active
Sonotrax Series Ultrasonic Pocket Doppler	K101960	FDA 510(k)	Class II	Active
Acclarix AX8 Diagnostic Ultrasound System	K161300	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

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.

Edan Instruments, Inc. US