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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 6 of 11

Device	Model / Reference	Registries	Class	Status
ECG Cable	DECG-P	EUDAMED	Class I	Active
ECG Cable	EC03DAG061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC05DAS1211	EUDAMED	Class I	Active
ECG Cable	EL03DAGY1	EUDAMEDFDA UDI	Class I	Active
Video Colposcope	C6A HD	EUDAMEDFDA UDI	Class I	Active
Patient Monitor	iM50	EUDAMEDFDA UDI	Class IIb	Active
Connection Cable	01.57.472017	EUDAMED	Class I	Active
ECG Cable	ET03DGS062	EUDAMEDFDA UDI	Class I	Active
Connection Cable	02.57.471280	EUDAMEDFDA UDI	Class I	Active
Trolley (for medical use)	MT-803	EUDAMED	Class I	Active
Biofeedback and Stimulation System	PA4	EUDAMED	Class IIa	Active
Hematology Analyzer	H69	EUDAMED	Class B	Active
Connection Cable	01.57.471972	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03DAG121	EUDAMEDFDA UDI	Class I	Active
Fetal & Maternal Monitor	F9	EUDAMEDFDA UDI	Class IIb	Active
ECG Cable	EC03DIG121	EUDAMEDFDA UDI	Class I	Active
Hematology Analyzer	H95	EUDAMED	Class B	Active
Electrocardiograph	SE-18	EUDAMEDFDA UDI	Class IIa	Active
ECG Cable	EC05DAS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC05DIG121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	DECG-FQ	EUDAMED	Class I	Active
Hematology Analyzer	H68	EUDAMED	IVD General	Active
Telemetry Transmitter	iT20	EUDAMEDFDA UDI	Class IIb	Active
Calibrant Fluid Pack	i20CP100	EUDAMED	IVD General	Active
Trolley (for medical use)	MT-503N	EUDAMED	Class I	Active
Hematology Analyzer	H68S	EUDAMED	Class B	Active
Wall Mounting Bracket	WMB-01	EUDAMED	Class I	Active
Connection Cable	01.13.037477	EUDAMED	Class I	Active
Trolley (for medical use)	MT-809	EUDAMED	Class I	Active
Hematology Analyzer	iH30 Pro	EUDAMED	IVD General	Active
Blood Gas and Chemistry Analyzer	i15	EUDAMEDFDA UDI	Class A	Active
Blood Gas and Chemistry Analyzer	i2005	EUDAMED	IVD General	Active
Ultrasonic TableTop Doppler	SD5	EUDAMEDFDA UDI	Class IIa	Active
Hematology Analyzer	H95S	EUDAMED	Class B	Active
ECG Cable	RPAYACC015	EUDAMED	Class I	Active
Trolley（for medical use）	MT-300	EUDAMED	Class I	Active
Fetal Monitor	F2	EUDAMEDFDA UDI	Class IIb	Active
Holter System	SE-3012	EUDAMEDFDA UDI	Class IIa	Active
ECG Cable	ET05EGS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03DAB061	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	iBG4	EUDAMED	IVD General	Active
ECG Cable	RPAYACC030	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	iBG8-OXI	EUDAMED	IVD General	Active
Connection Cable	SHEC1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL03NASN1	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL03DASY1	EUDAMEDFDA UDI	Class I	Active
Connection Cable	01.57.471027	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET05EGS062	EUDAMEDFDA UDI	Class I	Active
Diagnostic Ultrasound System	Acclarix AX3	EUDAMEDFDA UDI	Class IIa	Active
ECG Cable	RPAYACC010	EUDAMEDFDA UDI	Class I	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