Question 1

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

Accepted Answer

Shenzhen Finicare Co., Ltd. specializes in infrared thermometers, electronic thermometers, and upper arm electronic blood pressure monitors. The infrared thermometers are designed for non-contact temperature measurement, while the electronic thermometers can be used for oral, axillary, or tympanic readings. Additionally, the company produces upper arm blood pressure monitors intended for both home and clinical use, often branded under different product lines.

Question 2

Where is Shenzhen Finicare Co., Ltd. based?

Accepted Answer

Shenzhen Finicare Co., Ltd. is based in China. The company’s manufacturing and operations are centered in Shenzhen, which is a key hub for medical device production in the region.

Question 3

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

Accepted Answer

Shenzhen Finicare Co., Ltd.’s devices are listed in the euDAMED registry, which is the European database for medical devices. This registry is used to track devices that comply with EU medical device regulations, ensuring transparency and traceability for authorized products.

Question 4

How are Shenzhen Finicare Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Shenzhen Finicare Co., Ltd.’s devices fall under Class IIa classification in the EU. This classification is assigned based on the risk associated with the device—Class IIa devices pose a moderate risk and require compliance with specific design controls, clinical evaluations, and conformity assessment procedures to ensure safety and performance.

Question 5

Are Shenzhen Finicare Co., Ltd.’s devices intended for use outside the EU?

Accepted Answer

The provided information focuses on the company’s devices being classified under Class IIa in the EU and listed in euDAMED, indicating regulatory compliance within the European market. While the company manufactures these products, their intended use and regulatory pathways in other regions (such as the US, Japan, or other non-EU markets) would depend on local regulations and authorizations, which are not specified here.

Device	Model / Reference	Registries	Class	Status
TIV MED Infrared Thermometer	FC-IR202	EUDAMED	Class IIa	Active
OffiSoins Upper Arm Electronic Blood Pressure Monitor	FC-BP120	EUDAMED	Class IIa	Active
TIV MED Electronic thermometer	FC-TM132	EUDAMED	Class IIa	Active
TIV MED Upper Arm Electronic Blood Pressure Monitor	FC-BP120	EUDAMED	Class IIa	Active
Finicare	FC-IR1011	FDA UDI	Class II	Active
Electronic thermometer	FC-TM112	EUDAMED	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor（getwell）	FC-BP101	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR200	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR200	EUDAMED	Class IIa	Active
poleet	FC-BP200	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer-HIMMELSHAUCH	FC-IR1030	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR209	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR200	EUDAMED	Class IIa	Active
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)	K243136	FDA 510(k)	Class II	Active
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112)	K220113	FDA 510(k)	Class II	Active
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221)	K231367	FDA 510(k)	Class II	Active
Upper Arm Electronic Blood Pressure Monitor（WAJ）	FC-BP113	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM132	EUDAMED	Class IIa	Active
Electronic thermometer	FC-TM111	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR101	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM110	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR206	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR202	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP102	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor（getwell）	FC-BP101	EUDAMED	Class IIa	Active
Wrist Electronic Blood Pressure Monitor(OffiSoins)	FC-BP201	EUDAMED	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP100	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM101	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR1030	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor(AIRCASE)	FC-BP131	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR105	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP121	EUDAMEDFDA UDI	Class IIa	Active
Wrist Electronic Blood Pressure Monitor	FC-BP201	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR3010	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR109	EUDAMED	Class IIa	Active
Wrist Electronic Blood Pressure Monitor	FC-BP211	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM130	EUDAMED	Class IIa	Active
Wrist Electronic Blood Pressure Monitor	FC-BP221	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP111	EUDAMEDFDA UDI	Class IIa	Active
Dr. Max Infrared Thermometer	FC-IR200	EUDAMED	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP131	EUDAMED	Class IIa	Active
OffiSoins Infrared Thermometer	FC-IR100	EUDAMED	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP120	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR205	EUDAMEDFDA UDI	Class IIa	Active
Infrared Thermometer	FC-IR400	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM131	EUDAMED	Class IIa	Active
Electronic thermometer	FC-TM100	EUDAMED	Class IIa	Active
Infrared Thermometer	FC-IR300	EUDAMEDFDA UDI	Class IIa	Active
Upper Arm Electronic Blood Pressure Monitor	FC-BP130	EUDAMEDFDA UDI	Class IIa	Active
Electronic thermometer	FC-TM120	EUDAMED	Class IIa	Active

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