Question 1

What types of medical devices does Shenzhen Jumper Medical Equipment Co., Ltd. manufacture?

Accepted Answer

Shenzhen Jumper Medical Equipment Co., Ltd. specializes in non-invasive patient monitoring devices. Their product range includes fetal Doppler units for prenatal monitoring, pulse oximeters to measure blood oxygen levels, electronic blood pressure monitors for hypertension management, and infrared thermometers like the COMED model for temperature assessment. They also produce a Bluetooth-enabled oximeter for continuous monitoring, ensuring a focus on real-time health tracking.

Question 2

Where is Shenzhen Jumper Medical Equipment Co., Ltd. based?

Accepted Answer

The company is headquartered in Shenzhen, China. This location reflects its position as a manufacturer within the global medical device industry, though its regulatory compliance and device listings apply internationally where applicable.

Question 3

Which regulatory registries list devices from Shenzhen Jumper Medical Equipment Co., Ltd.?

Accepted Answer

Devices from Shenzhen Jumper Medical Equipment Co., Ltd. are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion is required for compliance under the EU Medical Device Regulation (MDR) and ensures transparency for authorized devices within the EU market.

Question 4

How are Shenzhen Jumper Medical Equipment Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

All devices manufactured by Shenzhen Jumper Medical Equipment Co., Ltd. fall under Class IIa classification in the EU Medical Device Regulation. This classification applies to devices that pose a low to moderate risk, such as non-invasive monitoring tools like pulse oximeters, blood pressure monitors, and fetal Dopplers, which require additional scrutiny beyond general medical devices but do not pose high-risk concerns.

Device	Model / Reference	Registries	Class	Status
Fetal Doppler	JPD-200C+	EUDAMED	Class IIa	Active
Fetal Doppler	JPD-100E+	EUDAMEDFDA UDI	Class IIa	Active
TrueLife Oximeter X5 BT	JPD-500F	EUDAMED	Class IIa	Active
Medicare	JPD-FR204	EUDAMED	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA100	EUDAMEDFDA UDI	Class IIa	Active
Fetal Doppler	JPD-100S6+	EUDAMED	Class IIa	Active
Fetal Doppler	JPD-100S4	EUDAMEDFDA UDI	Class IIa	Active
Wireless Intelligent Thermometer	K182437	FDA 510(k)	Class II	Active
Fetal Ultrasonic Monitor And Accessories	K131457	FDA 510(k)	Class II	Active
Fingertip Pulse Oximeter	K170965	FDA 510(k)	Class II	Active
Non-Contact Infrared Thermometer	K131243	FDA 510(k)	Class II	Active
Fingertip Pulse Oximeter	K140582	FDA 510(k)	Class II	Active
Mini TENS Therapy Device	K182871	FDA 510(k)	Class II	Active
Infrared Thermometer	JPD-FR415	EUDAMED	Class IIa	Active
Medicare	JPD-500F	EUDAMED	Class IIa	Active
Pulse Oximeter	JPD-500A	EUDAMEDFDA UDI	Class IIa	Active
Fetal Doppler	JPD-200S	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR403	EUDAMEDFDA UDI	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA101	EUDAMEDFDA UDI	Class IIa	Active
Pulse Oximeter	JPD-501F	EUDAMEDFDA UDI	Class IIa	Active
Pulse Oximeter	JPD-500F	EUDAMEDFDA UDI	Class IIa	Active
Electronic Blood Pressure Monitor	WHA10	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR401	EUDAMEDFDA UDI	Class IIa	Active
TENS Therapy Device	JPD-ES210	EUDAMED	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HW100A	EUDAMED	Class IIa	Active
Pulse Oximeter	JPD-502G	EUDAMEDFDA UDI	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA200	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR409-BT	EUDAMED	Class IIa	Active
Fetal Doppler	JPD-100A2	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR300	EUDAMED	Class IIa	Active
COMED Infrared Thermometer	JPD-FR202	EUDAMED	Class IIa	Active
Infrared Thermometer	JPD-FR205	EUDAMEDFDA UDI	Class IIa	Active
Pulse Oximeter	JPD-510E	EUDAMEDFDA UDI	Class IIa	Active
Pulse Oximeters	JPD-500F	EUDAMED	Class IIa	Active
Pulse Oximeter	JPD-510I	EUDAMED	Class IIa	Active
Fetal Doppler	JPD-200C	EUDAMED	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA121	EUDAMEDFDA UDI	Class IIa	Active
Misure	JPD-FR301	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR304	EUDAMED	Class IIa	Active
Electronic Blood Pressure Monitor	WHA20	EUDAMEDFDA UDI	Class IIa	Active
Fetal Doppler	JPD-100A	EUDAMEDFDA UDI	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA200C	EUDAMEDFDA UDI	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA300	EUDAMED	Class IIa	Active
pulox	JPD-FR202	EUDAMED	Class IIa	Active
Fetal Doppler	JPD-100S(mini)	EUDAMED	Class IIa	Active
Pulse Oximeter	JPD-500D	EUDAMEDFDA UDI	Class IIa	Active
Fetal Doppler	JPD-100B	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	JPD-FR418	EUDAMED	Class IIa	Active
Fetal Monitor	JPD-300Pa	EUDAMED	Class IIa	Active
Electronic Blood Pressure Monitor	JPD-HA210	EUDAMEDFDA UDI	Class IIa	Active

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