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
Multi-parameter Patient Monitor	N15C	EUDAMED	Class IIb	Active
Disposable SpO2 sensor	CM-M02-023	EUDAMED	Class IIb	Active
Ventilator	NV60B	EUDAMED	Class IIb	Active
LED Surgical Light	L5	EUDAMED	Class I	Active
Temperature Sensor	CM-M03-001	EUDAMED	Class IIb	Active
LED Surgical Light	L5-D	EUDAMED	Class I	Active
Multi-parameter patient monitor	MR-M60T	EUDAMED	Class IIb	Active
Lower Gastrointestinal Video Endoscope	EC-A30P	EUDAMED	Class IIa	Active
Multi-parameter Patient Monitor	N12C	EUDAMED	Class IIb	Active
Ventilator	NV70B	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	OPUS i10	EUDAMED	Class IIb	Active
NIBP Cuff	CM-M04-017	EUDAMED	Class I	Active
Multi-parameter patient monitor	ND15	EUDAMED	Class IIb	Active
Electrocardiograph	H12A	EUDAMED	Class IIa	Active
LED Surgical Light	L8A-QC/L7-QC	EUDAMED	Class I	Active
LED Surgical Light	L5-DCD	EUDAMED	Class I	Active
Infusion Pump	ME660A	EUDAMED	Class IIb	Active
Specialized Cardiovascular Monitor	C100	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	N15MAPro	EUDAMED	Class IIb	Active
Medical Endoscopic Light Source	ELS-2000U	EUDAMED	Class IIa	Active
Neonatal and Pediatric Ventilators	VN8S HFO	EUDAMED	Class IIb	Active
Video Laryngoscope	CVL-1	EUDAMED	Class I	Active
Multi-parameter Patient Monitor	C100A	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	UD70	EUDAMED	Class IIb	Active
Medical Endoscopic Video Processor	EIS-2000X	EUDAMED	Class IIa	Active
Multi-parameter Patient Monitor	STAR8000A	EUDAMED	Class IIb	Active
Specialized Cardiovascular Monitor	C100B	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	ND30	EUDAMED	Class IIb	Active
Neonatal and Pediatric Ventilators	VN8S	EUDAMED	Class IIb	Active
Compression Cuff	HM-01-L	EUDAMED	Class I	Active
Medical Endoscopic Light Source	ELS-1500U	EUDAMED	Class IIa	Active
Compression Cuff	HM-01-S	EUDAMED	Class I	Active
NIBP Cuff	CM-M04-011	EUDAMED	Class I	Active
Ventilator	V3A Pro	EUDAMED	Class IIb	Active
LED Surgical Light	L9B/L9B/ L9A	EUDAMED	Class I	Active
High Flow Heated Respiratory Humidifier	NF3	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	C500	EUDAMED	Class IIb	Active
ECG Cable	CM-M01-013	EUDAMED	Class I	Active
Infrared Ear thermometer	IRT10	EUDAMED	Class IIa	Active
LED Surgical Light	L9B-DC	EUDAMED	Class I	Active
Multi-parameter patient monitor	ND12A	EUDAMED	Class IIb	Active
Automatic CPR Machine	ES3	EUDAMED	Class IIb	Active
Ventilator	V8A	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	ND15C	EUDAMED	Class IIb	Active
Lower Gastrointestinal Video Endoscope	EC-A20PL	EUDAMED	Class IIa	Active
LED Surgical Light	L6-SCC	EUDAMED	Class I	Active
LED Surgical Light	L7-SC	EUDAMED	Class I	Active
Probe Cleanser	/	EUDAMED	IVD General	Active
LED Surgical Light	L3-DCA	EUDAMED	Class I	Active
Multi-parameter Patient Monitor	C70A	EUDAMED	Class IIb	Active

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