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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 8 of 11

Device	Model / Reference	Registries	Class	Status
Fetal & Maternal Monitor	F15	EUDAMEDFDA 510(k)	Class IIb	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
Calibrant Fluid Pack	CP50	EUDAMED	IVD General	Active
ECG Cable	FECG-3ISU	EUDAMED	Class I	Active
ECG Cable	RPAYACC032	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
ECG Cable	01.57.101027	EUDAMED	Class I	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
Diagnostic Ultrasound System	U2	EUDAMEDFDA UDI	Class IIa	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Vital Signs Monitor	iM3	EUDAMEDFDA UDI	Class IIb	Active
Data Management Software	CMS-LITE	EUDAMED	Class I	Active
ECG Cable	EC03EAS121	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC033	EUDAMEDFDA UDI	Class I	Active
Trolley (for medical use)	MT-805	EUDAMED	Class I	Active
Ultrasonic Pocket Doppler	SD2	EUDAMEDFDA UDI	Class IIa	Active
Patient Monitor	Neptune	EUDAMEDFDA UDI	Class IIb	Active
ECG Cable	RPAYACC016	EUDAMEDFDA UDI	Class I	Active
Dye	HF93R	EUDAMED	Class A	Active
Vital Signs Monitor	iM3s	EUDAMEDFDA UDI	Class IIb	Active
Trolley (for medical use)	PR Rocker Trolley	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
EMG/Stimulation sensor	SK60130WF-R	EUDAMED	Class I	Active
Central Monitoring System	MFM-CMS	EUDAMEDFDA UDI	Class IIb	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
ECG Cable	ET10DIS121	EUDAMEDFDA UDI	Class I	Active
Lyse	HL91D	EUDAMED	Class A	Active
Connection Cable	01.57.471789	EUDAMEDFDA UDI	Class I	Active
Blood Gas and Chemistry Analyzer	i20	EUDAMED	IVD General	Active
Blood Gas and Chemistry Analyzer	i15A	EUDAMED	Class A	Active
Test Cartridge	BG10	EUDAMED	IVD General	Active
ECG Cable	EC05DIS061	EUDAMEDFDA UDI	Class I	Active
Video Colposcope	C12 UHD	EUDAMEDFDA UDI	Class I	Active
ECG Cable	ET03DGS121	EUDAMEDFDA UDI	Class I	Active
NIBP Cuff	Infant E5	EUDAMEDFDA UDI	Class I	Active
ECG Cable	iT30-EL6DASHO1	EUDAMED	Class I	Active
Hematology Analyzer	H69S	EUDAMED	IVD General	Active
Lyse	HL90H	EUDAMED	Class A	Active
Test Cartridge	BG10	EUDAMED	IVD General	Active
Controls	CO-Oximeter Control Level 3	EUDAMED	IVD General	Active
ECG Cable	RPAYACC011	EUDAMED	Class I	Active
Connection Cable	01.13.036652	EUDAMED	Class I	Active
Video Colposcope	C9 HD	EUDAMED	Class I	Active
Test Cartridge	iBG4	EUDAMED	IVD General	Active
ECG Cable	EC03DAG1211	EUDAMED	Class I	Active
Biofeedback and Stimulation System	P4	EUDAMED	Class IIa	Active
ECG Cable	RPAYACC012	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC008	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BC4	EUDAMED	IVD General	Active
Test Cartridge	iBG3	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