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
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
ECG Cable	CM-M01-013	EUDAMED	Class I	Active
Multi-parameter patient monitor	ND12A	EUDAMED	Class IIb	Active
Automatic CPR Machine	ES3	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	ND15C	EUDAMED	Class IIb	Active
LED Surgical Light	L6-SCC	EUDAMED	Class I	Active
Probe Cleanser	/	EUDAMED	IVD General	Active
Multi-parameter Patient Monitor	C70A	EUDAMED	Class IIb	Active
Neonatal and Pediatric Ventilators	VN8	EUDAMED	Class IIb	Active
Fetal & Maternal Monitor	STAR5000A	EUDAMED	Class IIb	Active
NIBP Cuff	CM-M04-018	EUDAMED	Class I	Active
Compression Cuff	FO-01-L-F	EUDAMED	Class I	Active
Compression Cuff	HO-01	EUDAMED	Class I	Active
Vital Signs Monitor	NC7Neo	EUDAMED	Class IIb	Active
Electric Bronchoscope	EB28	EUDAMED	Class IIa	Active
Linear array ultrasound probe	L25	EUDAMED	Class IIa	Active
LED Surgical Light	L7	EUDAMED	Class I	Active
LED Surgical Light	L8B/L7	EUDAMED	Class I	Active
ECG Cable	CM-M01-014	EUDAMED	Class I	Active
LED Surgical Light	L6-SC	EUDAMED	Class I	Active
LED Surgical Light	L9B-DC/L9B-DC/L9A-DC	EUDAMED	Class I	Active
Multi-parameter patient monitor	MR-M80T	EUDAMED	Class IIb	Active
Neonatal Phototherapy Bed	BL20A	EUDAMED	Class IIa	Active
ECG Cable	CM-M01-053	EUDAMED	Class I	Active
Multi-parameter Patient Monitor	K22A pro	EUDAMED	Class IIb	Active
LED Surgical Light	L8B-SC/L7-SC	EUDAMED	Class I	Active
Specialized Fetal & Maternal Monitor	C26	EUDAMED	Class IIb	Active
Compression Cuff	FO-02-N	EUDAMED	Class I	Active
Ventilator	V5A	EUDAMED	Class IIb	Active
High Flow Heated Respiratory Humidifier	NF1	EUDAMED	Class IIb	Active
Infant Phototherapy Equipment	BL60A	EUDAMED	Class IIa	Active
ECG Cable	CM-M01-058	EUDAMED	Class I	Active
Fetal & Maternal Monitor	STAR5000	EUDAMED	Class IIb	Active
Syringe Pump	M800A	EUDAMED	Class IIb	Active
Electric Bronchoscope	EB38	EUDAMED	Class IIa	Active
Compression Cuff	FM-05-P	EUDAMED	Class I	Active
Ceiling Pendant	D9	EUDAMED	Class IIb	Active
C-Reactive Protein Calibrator	6590-ER00001	EUDAMED	IVD General	Active
LED Surgical Light	L8B-DC	EUDAMED	Class I	Active
Medical Oxygen-air blenders	KL-20	EUDAMED	Class IIb	Active
Multi-parameter Patient Monitor	NC8A	EUDAMED	Class IIb	Active
Multi-parameter patient monitor	N15M	EUDAMED	Class IIb	Active
Compression Cuff	FM-02-L	EUDAMED	Class I	Active
Multi-parameter Patient Monitor	NC12A	EUDAMED	Class IIb	Active
Compression Cuff	FO-01-P-F	EUDAMED	Class I	Active
Sterile Disposable Laryngoscope Blade	CVL-1-1	EUDAMED	Class I	Active

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