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GENTEC (SHANGHAI) CORPORATION

China·CN-MF-000012841

Last updated September 17, 2026

Information

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
Gentec®	35I-N2O Series	FDA UDI	Class I	Active
Gentec®	881VR-200-00-T	FDA UDI	Class II	Unknown
Gentec®	GMX120E-AIR/O2	FDA UDI	Class II	Active
Gentec®	882VR-200-OH-C	FDA UDI	Class II	Active
Gentec®	881VR-300-DH-T	FDA UDI	Class II	Active
Gentec®	882VR-760-CH-T	FDA UDI	Class II	Active
Gentec®	881VR-160-CH-A	FDA UDI	Class II	Active
Gentec®	881VR-300-OH-B	FDA UDI	Class II	Active
Gentec®	881VR-300-00-A	FDA UDI	Class II	Active
Gentec®	881VR-300D-OH-D	FDA UDI	Class II	Active
Gentec®	882VR-300-OE-D	FDA UDI	Class II	Active
Gentec®	881VR-160-PB-B	FDA UDI	Class II	Active
Ohio®	0321-7815-800	FDA UDI	Class II	Active
GMX Series Medical Air/Oxygen Blender	K142291	FDA 510(k)	Class II	Active
Low-Pressure Hose Assemblies for use with Medical Gases (Pressure)	34I-OXY	EUDAMED	Class IIa	Active
Medical Flow Meter For Terminal Units of Medical Gas Pipe System	FM197A-15L	EUDAMEDFDA UDI	Class IIa	Active
Medical Suction Equipment (Powered from Vacuum)	881VR-160	EUDAMED	Class IIa	Active
Medical Flow Meter For Terminal Units of Medical Gas Pipe System	DESF-03	EUDAMEDFDA UDI	Class IIa	Active
High Flow Nasal Cannula	681-101 ( Adult L )	EUDAMED	Class IIa	Active
Respiratory Tract Humidifiers for Medical Use	7100R	EUDAMED	Class IIa	Active

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