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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 11 of 11

Device	Model / Reference	Registries	Class	Status
Dye	HF91D	EUDAMED	Class A	Active
ECG Cable	MECG-IS	EUDAMED	Class I	Active
ECG Cable	EC03EAG061	EUDAMEDFDA UDI	Class I	Active
Connection Cable	01.57.471836	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC008	EUDAMEDFDA UDI	Class I	Active
Diagnostic Ultrasound System	Acclarix GX9	EUDAMEDFDA 510(k)FDA UDI	Class IIa	Active
ECG Cable	EC05EAG121	EUDAMEDFDA UDI	Class I	Active
Connection Cable	DT0504DB963	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG4	EUDAMED	IVD General	Active
ECG Cable	RPAYACC031	EUDAMEDFDA UDI	Class I	Active
Lyse	HL620	EUDAMED	Class A	Active
ECG Cable	RPAYACC018	EUDAMEDFDA UDI	Class I	Active
EMG/Stimulation sensor	SK5050WF-F	EUDAMED	Class I	Active
Electrocardiograph	SE-1201 Pro	EUDAMEDFDA UDI	Class IIa	Active
Hematology Analyzer	H31 Pro	EUDAMED	Class B	Active
ECG Cable	ET03DGS122	EUDAMEDFDA UDI	Class I	Active
Calibrant Fluid Pack	CP100	EUDAMED	IVD General	Active
ECG Cable	EL03DIGY1	EUDAMEDFDA UDI	Class I	Active
Connection Cable	SPO2C7D9	EUDAMED	Class I	Active
Test Cartridge	iBG8-OXI	EUDAMED	IVD General	Active
ECG Cable	EC05DAS061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET10DAS1211	EUDAMED	Class I	Active
Connection Cable	01.57.471071	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET05EGS061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	iT30-EL3DASHO1	EUDAMED	Class I	Active
Biofeedback and Stimulation System	PR8	EUDAMED	Class IIa	Active
Controls	Blood Gas and Electrolyte Control Level 2	EUDAMED	IVD General	Active
ECG Cable	RPAYACC028	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL03NIGS1	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BG3	EUDAMED	IVD General	Active
Connection Cable	SPO20902A7	EUDAMED	Class I	Active
Connection Cable	01.57.471166	EUDAMEDFDA UDI	Class I	Active
Calibrant Fluid Pack	CP50	EUDAMED	IVD General	Active
ECG Cable	EC05DAG061	EUDAMEDFDA UDI	Class I	Active
Controls	Blood Gas and Electrolyte Control Level 2	EUDAMED	IVD General	Active
Hematology Control	ED-60D	EUDAMED	Class B	Active
Controls	CO-Oximeter Control Level 1	EUDAMEDFDA UDI	IVD General	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
ECG Cable	EL03DISY1	EUDAMEDFDA UDI	Class I	Active
Controls	Blood Gas and Electrolyte Control Level 1	EUDAMED	IVD General	Active
Connection Cable	01.57.471070	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC025	EUDAMED	Class I	Active
Lyse	HL600	EUDAMED	Class A	Active
Blood Gas and Chemistry Analyzer	i500	EUDAMED	Class A	Active
ECG Cable	ET05DGS061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL05DIGY1	EUDAMEDFDA UDI	Class I	Active
Controls	CO-Oximeter Control Level 1	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

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

Edan Instruments, Inc. US