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
NIBP Cuff	CM-M04-019	EUDAMED	Class I	Active
ECG Cable	CM-M01-018	EUDAMED	Class I	Active
Hematology Analyzer LYSE	/	EUDAMED	IVD General	Active
Disposable SpO2 sensor	CM-M02-025	EUDAMED	Class IIb	Active
ECG Cable	CM-M01-057	EUDAMED	Class I	Active
Infant Phototherapy Equipment	BL70	EUDAMED	Class IIa	Active
Multi-parameter patient monitor	ND10A	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	N15	EUDAMED	Class IIb	Active
Electrocardiograph	/	EUDAMED	Class IIa	Active
Hematology Control	/	EUDAMED	IVD General	Active
Specialized Neonatal Monitor	K80A	EUDAMED	Class IIb	Active
LED Surgical Light	L9B-SC/L9A-SC	EUDAMED	Class I	Active
Multi-parameter Patient Monitor	Datalys 780	EUDAMEDFDA 510(k)	Class IIb	Active
Lower Gastrointestinal Video Endoscope	EC-A20P	EUDAMED	Class IIa	Active
Anesthesia Machine	AX-500A	EUDAMED	Class IIb	Active
Neonatal Phototherapy Bed	BL20B	EUDAMED	Class IIa	Active
Compression Cuff	FO-02-F	EUDAMED	Class I	Active
Reusable SpO2 sensor	CM-M02-009	EUDAMED	Class IIb	Active
Hematology Control	/	EUDAMED	IVD General	Active
Multi-parameter Patient Monitor	NC8	EUDAMED	Class IIb	Active
Medical Examination Light	BL10A	EUDAMED	Class I	Active
Multi-parameter patient monitor	ND60	EUDAMED	Class IIb	Active
Emergency and Transport Ventilator	V1A	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	NC10	EUDAMED	Class IIb	Active
LED Surgical Light	L6SCB	EUDAMED	Class I	Active
Diagnostic Ultrasound System	EP50PT	EUDAMED	Class IIa	Active
Medical Endoscopic Video Processor	EIS-1500Pro	EUDAMED	Class IIa	Active
Electrocardiograph	/	EUDAMED	Class IIa	Active
Reusable SpO2 sensor	CM-M02-001	EUDAMED	Class IIb	Active

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