Question 1

What types of medical devices does Shenzhen Aeon Technology Co., Ltd. manufacture?

Accepted Answer

Shenzhen Aeon Technology Co., Ltd. specializes in devices for patient monitoring and therapy, including disposable and reusable pulse oximeters (for measuring blood oxygen saturation and heart rate), infrared skin thermometers (for body temperature monitoring), compressor nebulizers (for delivering inhaled medications), and TENS/EMS units (for pain relief via electrical stimulation). These devices cater to clinical and home-use settings.

Question 2

Where is Shenzhen Aeon Technology Co., Ltd. based, and how does that affect its devices?

Accepted Answer

The company is headquartered in China. While the country of origin does not inherently determine regulatory classification or compliance, its devices are designed to meet international standards like those of the EU (Class II/IIa) and the FDA (Class II/IIa), ensuring they can be registered in global databases such as EUDAMED and the FDA’s UDI system.

Question 3

Which regulatory registries list Shenzhen Aeon Technology Co., Ltd.’s devices?

Accepted Answer

The company’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) database, which tracks devices authorized in the U.S. These listings help healthcare providers and regulators verify compliance and traceability for Class II/IIa devices.

Question 4

How are Shenzhen Aeon Technology Co., Ltd.’s devices classified under EU and FDA regulations?

Accepted Answer

The company’s devices fall under Class II and Class IIa classifications in both the EU and FDA frameworks. This classification is based on their intended use—for example, pulse oximeters and nebulizers are considered higher-risk due to their role in critical monitoring or therapy, requiring stricter regulatory oversight and compliance with specific safety and performance standards.

Device	Model / Reference	Registries	Class	Status
Dr. Aid	U80N	FDA UDI	Class II	Active
Accuro	U807	FDA UDI	Class II	Active
Wristech	U60A	FDA UDI	Class II	Active
Huheta	UFR101	FDA UDI	Class II	Active
Vicsainteck	AS1080	FDA UDI	Class II	Active
Brilnurse	U81NH	FDA UDI	Class II	Active
Tovendor	U60AH	FDA UDI	Class II	Active
Baseline Evaluation Instruments	U60E	FDA UDI	Class II	Active
Urbest	U80H	FDA UDI	Class II	Active
AlphaMed	06953825909697	EUDAMEDFDA UDI	Class IIa	Active
Compressor Nebulizer	A500LWDC05	EUDAMED	Class IIa	Active
ingencare	06953825910679	EUDAMED	Class IIa	Active
Compressor Nebulizer	A500LWDC04	EUDAMED	Class IIa	Active
Alphamed	06953825903985	EUDAMEDFDA UDI	Class IIa	Active
BP MeterX	06953825909390	EUDAMED	Class IIa	Active
Novλcardix	06953825910426	EUDAMED	Class IIa	Active
Alphamed	06953825905743	EUDAMEDFDA UDI	Class IIa	Active
Rotopata	06953825907457	EUDAMEDFDA UDI	Class IIa	Active
Alphamed	06953825904227	EUDAMEDFDA UDI	Class IIa	Active
Compressor Nebulizer	A500LW08	EUDAMED	Class IIa	Active
Inframeter Xt	06953825910068	EUDAMED	Class IIa	Active
Alphamed	06953825904043	EUDAMEDFDA UDI	Class IIa	Active
Alphamed	06953825905408	EUDAMEDFDA UDI	Class IIa	Active
Pvs First Aid	06953825910839	EUDAMED	Class IIa	Active
Alphamed	06953825908300	EUDAMEDFDA UDI	Class IIa	Active
TENS/EMS Unit	A621	EUDAMED	Class IIa	Active
Compressor Nebulizer	A500LW11	EUDAMED	Class IIa	Active
Autonomie et Bien être	06953825909048	EUDAMED	Class IIa	Active
DIATHER Care	06953825910228	EUDAMED	Class IIa	Active
Nature Therapy	06953825910518	EUDAMED	Class IIa	Active
U80 Series Upper Arm Electronic Blood Pressure Monitor	K160019	FDA 510(k)	Class II	Active
TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C, AS8016, AS8019, AS9020E, AS9026)	K243856	FDA 510(k)	Class II	Active
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)	K241007	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Infrared Thermometer	K200802	FDA 510(k)	Class II	Active
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y, U83Y, U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))	K243115	FDA 510(k)	Class II	Active
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B, U90B Pro, U90B Plus, U90B Ultra, U90C, U90C Pro, U90C Plus, U90C Ultra).)	K260273	FDA 510(k)	Class II	Active
Tens And Powered Muscle Stimulator	K143268	FDA 510(k)	Class II	Active
Air Compression Leg Massager (UM605, UM606, UM607, UM608, UM609, UM610, UM611, UM617)	K250046	FDA 510(k)	Class II	Active
Alphamed	06953825905811	EUDAMEDFDA UDI	Class IIa	Active
Alphamed	06953825908676	EUDAMEDFDA UDI	Class IIa	Active
Pulse Oximeter	A330	EUDAMEDFDA UDI	Class IIa	Active
Alphamed U90B Plus	06953825910990	EUDAMED	Class IIa	Active
Compressor Nebulizer	A500LW06	EUDAMED	Class IIa	Active
Compressor Nebulizer	A500LW05	EUDAMED	Class IIa	Active
HeartiPro	06953825910075	EUDAMED	Class IIa	Active
Alphamed	06953825908973	EUDAMEDFDA UDI	Class IIa	Active
Tens and Muscle stimulator	AS2015	EUDAMEDFDA UDI	Class IIa	Active
ALPhamed	06953825909338	EUDAMEDFDA UDI	Class IIa	Active
Misure	06953825906818	EUDAMED	Class IIa	Active
Alphamed	06953825906399	EUDAMEDFDA UDI	Class IIa	Active

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