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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 10 of 11

Device	Model / Reference	Registries	Class	Status
Hematology Analyzer	H60	EUDAMED	IVD General	Active
Calibrant Fluid Pack	i20CP200	EUDAMED	IVD General	Active
Trolley (for medical use)	MT-808	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
Connection Cable	01.57.471973	EUDAMEDFDA UDI	Class I	Active
Lyse	HL90H	EUDAMED	Class A	Active
Test Cartridge	iBC4	EUDAMED	IVD General	Active
Video Colposcope	C9 UHD	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC024	EUDAMEDFDA UDI	Class I	Active
Video Colposcope	C300A	EUDAMED	Class I	Active
Hematology Control	ED-90D	EUDAMED	Class B	Active
ECG Cable	RPAYACC005	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC05EAG061	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EC03EIG121	EUDAMEDFDA UDI	Class I	Active
Hematology Analyzer	H98S	EUDAMED	Class B	Active
Controls	Blood Gas and Electrolyte Control Level 1	EUDAMEDFDA UDI	IVD General	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Connection Cable	01.57.471663	EUDAMEDFDA UDI	Class I	Active
Diluent	HD310	EUDAMED	Class A	Active
Fetal Telemetry System	FTS-3	EUDAMEDFDA UDI	Class IIb	Active
Lyse	HL92N	EUDAMED	Class A	Active
Video Colposcope	C6 UHD	EUDAMED	Class I	Active
Test Cartridge	iBC4	EUDAMED	IVD General	Active
Trolley (for medical use)	PA Standard Trolley	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
ECG Cable	ET03DGS061	EUDAMEDFDA UDI	Class I	Active
Water Trap	02.01.210520	EUDAMEDFDA UDI	Class I	Active
Fetal Monitor	FTS-6 Mobile	EUDAMED	Class IIa	Active
Blood Sampler	isafeC-100AY	EUDAMED	Class A	Active
ECG Cable	EC05DIS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET03DGN061	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Pocket Doppler	SONOTRAX Vascular	EUDAMEDFDA UDI	Class IIa	Active
Temperature Probe	TP2AS22R01	EUDAMEDFDA UDI	Class IIb	Active
ECG Cable	RPAYACC002	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Pocket Doppler	SD1	EUDAMEDFDA UDI	Class IIa	Active
Diagnostic Ultrasound System	Acclarix AX7	EUDAMEDFDA UDI	Class IIa	Active
Test Cartridge	BC4	EUDAMED	IVD General	Active
ECG Cable	RPAYACC031	EUDAMED	Class I	Active
Connection Cable	01.57.471014	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
Calibrant Fluid Pack	CP100	EUDAMEDFDA 510(k)	IVD General	Active
Test Cartridge	iBG3	EUDAMED	IVD General	Active
Trolley (for medical use)	MT-503(S)	EUDAMED	Class I	Active
Controls	Blood Gas and Electrolyte Control Level 3	EUDAMEDFDA UDI	IVD General	Active
Connection Cable	01.57.472281	EUDAMED	Class I	Active
Calibrant Fuild Pack	i20CP100	EUDAMED	IVD General	Active
ECG Cable	EC05EIS061	EUDAMEDFDA UDI	Class I	Active
Video Colposcope	C3	EUDAMED	Class I	Active
Lyse	HL91D	EUDAMED	Class A	Active
Dye	HF91D	EUDAMED	Class A	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