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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 2 of 11

Device	Model / Reference	Registries	Class	Status
Blood Sampler	isafeP-3-C3A	EUDAMED	Class IIa	Active
Blood Sampler	isafeA-3	EUDAMED	Class IIa	Active
Blood Sampler	isafeA-3-C5A	EUDAMED	Class IIa	Active
ECG Analysis Software	AI-SEMIP	EUDAMED	Class IIa	Active
Blood Sampler	isafeA-3N	EUDAMED	Class IIa	Active
Finger Oximeter	H10B	EUDAMED	Class IIa	Active
Biofeedback and Stimulation System	Q1106	EUDAMED	Class IIa	Active
Blood Sampler	isafeP-3	EUDAMED	Class IIa	Active
Blood Sampler	isafeA-3-WA	EUDAMED	Class A	Active
Blood Sampler	isafeA-3-WA	EUDAMED	Class A	Active
Biofeedback and Stimulation System	P36	EUDAMED	Class IIa	Active
Biofeedback and Stimulation System	P4 Plus	EUDAMED	Class IIa	Active
NMT sensor	NMT-sensor	EUDAMED	Class I	Active
Blood Sampler	isafeA-1-C4A	EUDAMED	Class IIa	Active
Blood Sampler	isafeP-3	EUDAMED	Class IIa	Active
Test Cartridge	BG3	EUDAMED	IVD General	Active
Test Cartridge	iBG8	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
ECG Cable	RPAYACC007	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG4	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
ECG Cable	RPAYACC029	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG10	EUDAMED	IVD General	Active
Test Cartridge	BG10	EUDAMED	IVD General	Active
Lyse	HL91D	EUDAMED	Class A	Active
ECG Cable	RPAYACC025	EUDAMEDFDA UDI	Class I	Active
ECG Cable	RPAYACC008	EUDAMED	Class I	Active
Lyse	HL310	EUDAMED	Class A	Active
ECG Cable	RPAYACC032	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	iBG4	EUDAMED	IVD General	Active
ECG Cable	RPAYACC014	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BG3	EUDAMED	IVD General	Active
Lyse	HL620	EUDAMED	Class A	Active
Lyse	HL310	EUDAMED	Class A	Active
Test Cartridge	iBG4	EUDAMED	IVD General	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Dye	HF93R	EUDAMED	Class A	Active
ECG Cable	RPAYACC026	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
ECG Cable	RPAYACC015	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	MicroSample-BG4	EUDAMED	IVD General	Active
Dye	HF91D	EUDAMED	Class A	Active
Lyse	HL310	EUDAMED	Class A	Active
Test Cartridge	MicroSample-BG8	EUDAMED	IVD General	Active
Central Monitoring System	MFM-CNS	EUDAMEDFDA UDI	Class IIb	Active
ECG Cable	EC05EIG061	EUDAMEDFDA UDI	Class I	Active
SpO2 sensor	01.57.471746	EUDAMEDFDA UDI	Class IIb	Active
Connection Cable	01.57.471173	EUDAMEDFDA UDI	Class I	Active
Test Cartridge	BG8	EUDAMED	IVD General	Active
Connection Cable	SHEC5	EUDAMEDFDA UDI	Class I	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