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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 7 of 11

Device	Model / Reference	Registries	Class	Status
ECG Cable	RPAYACC027	EUDAMEDFDA UDI	Class I	Active
Trolley (for medical use)	MT-811	EUDAMED	Class I	Active
ECG Cable	RPAYACC019	EUDAMED	Class I	Active
Electrocardiograph	SE-1201	EUDAMEDFDA UDI	Class IIa	Active
Connection Cable	01.13.113617	EUDAMEDFDA UDI	Class I	Active
Dye	HF92N	EUDAMED	Class A	Active
ECG Cable	RPAYACC011	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Patient Monitor	iV12	EUDAMED	Class IIb	Active
Test Cartridge	BC4	EUDAMED	IVD General	Active
EEG electrodes	C20-M	EUDAMED	Class I	Active
EMG/Stimulation sensor	SK70120WF-F	EUDAMED	Class I	Active
ECG Cable	RPAYACC027	EUDAMED	Class I	Active
Telemetry Monitor	iT30	EUDAMED	Class IIb	Active
ECG Cable	EL06DAGS1	EUDAMEDFDA UDI	Class I	Active
Hematology Control	ED-30D Control H	EUDAMED	IVD General	Active
Holter ECG and ABP system	SA-20	EUDAMEDFDA UDI	Class IIa	Active
Patient Monitor	iX10	EUDAMEDFDA UDI	Class IIb	Active
Hematology Control	ED-30D	EUDAMED	IVD General	Active
Lyse	HL610	EUDAMED	Class A	Active
Connection Cable	01.57.472178	EUDAMED	Class I	Active
Patient Monitor	elite V5	EUDAMEDFDA UDI	Class IIb	Active
Finger Oximeter	H10	EUDAMED	Class IIa	Active
ECG Cable	EC05DIG061	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	iBG8	EUDAMED	IVD General	Active
Video Colposcope	iHC3A	EUDAMED	Class I	Active
Lyse	HL310	EUDAMED	Class A	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
Hematology Control	ED-60D Control L	EUDAMED	IVD General	Active
Lyse	HL91D	EUDAMED	Class A	Active
ECG Cable	RPAYACC007	EUDAMED	Class I	Active
Test Cartridge	MicroSample-BC4	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
Test Cartridge	BG4	EUDAMED	IVD General	Active
Video Colposcope	C6A	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC020	EUDAMEDFDA UDI	Class I	Active
Controls	Blood Gas and Electrolyte Control Level 2	EUDAMED	IVD General	Active
Video Colposcope	C6 HD	EUDAMED	Class I	Active
Connection Cable	01.57.471971	EUDAMEDFDA UDI	Class I	Active
Hematology control	ED-60D	EUDAMED	Class B	Active
ECG Cable	RPAYACC023	EUDAMEDFDA UDI	Class I	Active
ECG Cable	EL03NAGS1	EUDAMEDFDA UDI	Class I	Active
Hematology Control	ED-60D	EUDAMED	IVD General	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
SpO2 sensor	SH1	EUDAMEDFDA UDI	Class IIb	Active
Hematology Calibrator	ED-CAL PLUS	EUDAMED	IVD General	Active
ECG Cable	FECG-3ISL	EUDAMED	Class I	Active
ECG Cable	DECG-FP	EUDAMED	Class I	Active
Test Cartridge	BG10	EUDAMED	IVD General	Active
Cleaner	HC600	EUDAMED	Class A	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