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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 (546)

Page 9 of 11

Device	Model / Reference	Registries	Class	Status
Test Cartridge	BG8	EUDAMED	IVD General	Active
Pc Ecg	SE-1515	EUDAMEDFDA UDI	Class IIa	Active
Ambulatory Blood Pressure Monitor	SA-10	EUDAMEDFDA UDI	Class IIa	Active
ECG Cable	EL05NISS1	EUDAMEDFDA UDI	Class I	Active
Connection Cable	SHEC4	EUDAMEDFDA UDI	Class I	Active
Pc Ecg	PADECG	EUDAMEDFDA UDI	Class IIa	Active
Test Cartridge	MicroSample-BG4	EUDAMED	IVD General	Active
ECG Cable	EL10NISS1	EUDAMEDFDA UDI	Class I	Active
Lyse	HL90H	EUDAMED	Class A	Active
Diagnostic Ultrasound System	Acclarix LX3	EUDAMEDFDA UDI	Class IIa	Active
Test Cartridge	BC4	EUDAMED	IVD General	Active
Video Colposcope	C12A UHD	EUDAMEDFDA UDI	Class I	Active
Hematology Analyzer	H60S	EUDAMED	Class B	Active
ECG Cable	EL05NISS2	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
Connection Cable	01.57.471835	EUDAMEDFDA UDI	Class I	Active
Electrocardiograph	iSE-1210	EUDAMEDFDA UDI	Class IIa	Active
Connection Cable	02.57.471281	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL05NAGS2	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Test Cartridge	iBG8-OXI	EUDAMED	IVD General	Active
Patient Monitor	RespArray	EUDAMEDFDA UDI	Class IIb	Active
Diluent	HD93R	EUDAMED	Class A	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
Connection Cable	01.13.036357	EUDAMEDFDA UDI	Class I	Active
Patient Monitor	CX10	EUDAMEDFDA UDI	Class IIb	Active
ECG Cable	EL06DASS1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET05DGS062	EUDAMEDFDA UDI	Class I	Active
Connection Cable	SPO20902C7	EUDAMED	Class I	Active
ECG Cable	iT30-EL3DICHO1	EUDAMED	Class I	Active
ECG Cable	EC03DIG1211	EUDAMED	Class I	Active
Hematology Control	ED-30D Control N	EUDAMED	IVD General	Active
Hematology Analyzer	H66S	EUDAMED	IVD General	Active
Calibrant Fluid Pack	i20CP300	EUDAMED	IVD General	Active
Test Cartridge	BG4	EUDAMED	IVD General	Active
ECG Cable	RPAYACC010	EUDAMEDFDA UDI	Class I	Active
Hematology Analyzer	H66	EUDAMED	IVD General	Active
ECG Cable	EL03ISN1	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Pocket Doppler	SD3 LITE	EUDAMEDFDA UDI	Class IIa	Active
Video Colposcope	C9A UHD	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET03EGS061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL05NAGS1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC022	EUDAMED	Class I	Active
Hematology Control	ED-30D	EUDAMED	Class B	Active
Blood Sampler	isafeP-1	EUDAMED	Class IIa	Active
Connection Cable	01.57.472018	EUDAMED	Class I	Active
ECG Cable	EC03DIG061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET03EGS122	EUDAMEDFDA UDI	Class I	Active
Connection Cable	01.57.471975	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BG8	EUDAMED	IVD General	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