Question 1

What types of medical devices does Shenzhen Pacom Medical Instruments Co., Ltd. manufacture?

Accepted Answer

Shenzhen Pacom Medical Instruments Co., Ltd. specializes in infrared thermometers for clinical use. Their devices measure either skin temperature or a combination of ear and skin temperature, designed for non-invasive body temperature assessment in healthcare settings like hospitals and clinics.

Question 2

Where is Shenzhen Pacom Medical Instruments Co., Ltd. based?

Accepted Answer

The company is based in the United States, though its manufacturing operations are located in Shenzhen, China. The U.S. presence likely supports regulatory compliance and distribution within the American market.

Question 3

Which regulatory registries list Shenzhen Pacom Medical Instruments Co., Ltd.’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries reflect compliance with U.S. medical device regulations, ensuring traceability and regulatory oversight.

Question 4

How are Shenzhen Pacom Medical Instruments Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

All of Shenzhen Pacom Medical Instruments Co., Ltd.’s devices fall under Class II classification. This categorization applies to moderate-risk medical devices that require special controls beyond general controls to ensure safety and effectiveness, such as infrared thermometers used in clinical settings.

Question 5

Why are Shenzhen Pacom Medical Instruments Co., Ltd.’s devices listed in the FDA’s UDI system?

Accepted Answer

The Unique Device Identifier (UDI) system is mandated by the FDA to improve tracking and identification of medical devices throughout their lifecycle. By listing devices in this system, Shenzhen Pacom ensures better inventory management, recall efficiency, and compliance with post-market surveillance requirements for Class II infrared thermometers.

Device	Model / Reference	Registries	Class	Status
Anesthesia machine	X8	EUDAMED	Class IIb	Active
Syringe Pump	M800A-L	EUDAMED	Class IIb	Active
Anesthesia machine	X7	EUDAMED	Class IIb	Active
Bionso	PC828	FDA UDI	Class II	Active
Comen	C50	FDA UDI	Class II	Active
Infrared Thermometer	PC828	FDA UDI	Class II	Active
Fltr	PC801	FDA UDI	Class II	Active
Infrared Thermometer	PC816	FDA UDI	Class II	Active
Fltr	PC828	FDA UDI	Class II	Active
Infrared Thermometer	PC809	FDA UDI	Class II	Active
Fltr	PC868	FDA UDI	Class II	Active
Comen	C80	FDA UDI	Class II	Active
Infrared Thermometer	PC829	FDA UDI	Class II	Active
Comen	C60	FDA UDI	Class II	Active
Infrared Thermometer	PC868	FDA UDI	Class II	Active
Comen	C80	FDA UDI	Class II	Active
Fltr	PC828	FDA UDI	Class II	Active
Fltr	PC868	FDA UDI	Class II	Active
Comen	C30	FDA UDI	Class II	Active
Caroune	PC809	FDA UDI	Class II	Active
Comen	C50	FDA UDI	Class II	Active
Hematology Analyzer LYSE	/	EUDAMED	IVD General	Active
Specialized Fetal & Maternal Monitor	CF3A	EUDAMED	Class IIb	Active
LED Surgical Light	L3-DC	EUDAMED	Class I	Active
LED Surgical Light	L9B-DC/L9A-DC	EUDAMED	Class I	Active
Compression Cuff	FO-02-L	EUDAMED	Class I	Active
LED Surgical Light	L5-SCA	EUDAMED	Class I	Active
LED Surgical Light	L5-DCA	EUDAMED	Class I	Active
Ventilator	V3D	EUDAMED	Class IIb	Active
4K endoscopic camera system	VIS-60B	EUDAMED	Class I	Active
Electric Bronchoscope	EB52	EUDAMED	Class IIa	Active
Compression Cuff	FO-02-P-F	EUDAMED	Class I	Active
Vital Signs Monitor	NC3	EUDAMED	Class IIb	Active
LED Surgical Light	L8B-SC/L8A-SC	EUDAMED	Class I	Active
ECG Cable	CM-M01-010	EUDAMED	Class I	Active
Vital Signs Monitor	NC7	EUDAMED	Class IIb	Active
ECG Cable	CM-M01-056	EUDAMED	Class I	Active
Automatic Hematology Analyzer	CH8302CRP	EUDAMED	IVD General	Active
LED Surgical Light	L9B/L9A	EUDAMED	Class I	Active
Reusable SpO2 sensor	CM-M02-004	EUDAMED	Class IIb	Active
LED Surgical Light	L6	EUDAMED	Class I	Active
Hematology Calibrator	Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003	EUDAMED	IVD General	Active
Compression Cuff	HO-02-F	EUDAMED	Class I	Active
Ventilator	V3B Pro	EUDAMED	Class IIb	Active
Specialized Neonatal Monitor	C68	EUDAMED	Class IIb	Active
Medical Endoscopic Video Processor	EIS-2000U	EUDAMED	Class IIa	Active
Defibrillator Monitor	S2A	EUDAMED	Class IIb	Active
Anesthesia Machine	AX-800	EUDAMED	Class IIb	Active
Product name: Emergency and Transport Ventilator	EV2A	EUDAMED	Class IIb	Active
Electrocardiograph	/	EUDAMED	Class IIa	Active

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