Question 1

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

Accepted Answer

Shenzhen Creative Industry Co., Ltd. specializes in pulse oximeters, including wrist-mounted models, and multi-parameter spot-check systems designed for clinical use. Their product line also includes central monitoring systems for vital signs, capnography-enabled monitors, and devices specifically for sleep screening. These devices are engineered to measure and display physiological parameters like oxygen saturation, heart rate, and respiratory data.

Question 2

Where is Shenzhen Creative Industry Co., Ltd. based?

Accepted Answer

The company is headquartered in China. While the exact location within the country isn’t specified, its regulatory listings and device classifications align with international standards, indicating a focus on global markets.

Question 3

Which regulatory registries list devices manufactured by Shenzhen Creative Industry Co., Ltd.?

Accepted Answer

Devices from Shenzhen Creative Industry Co., Ltd. are listed in the EU’s eudamed database, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone regulatory evaluation for compliance with safety and performance standards in their respective markets.

Question 4

How are the devices produced by Shenzhen Creative Industry Co., Ltd. classified under regulatory frameworks?

Accepted Answer

The company’s devices fall under Class II, Class IIa, and Class IIb classifications. These classifications are determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required. For example, pulse oximeters and spot-check monitors are typically classified as Class II due to their role in monitoring critical physiological parameters, while more advanced systems (like those combining capnography) may fall into Class IIb due to additional risk considerations.

Device	Model / Reference	Registries	Class	Status
Vital Signs Minotor	AIView VS	EUDAMED	Class IIb	Active
Vital Signs Minotor	PC-900	EUDAMED	Class IIb	Active
Vital Signs Minotor	MS10	EUDAMED	Class IIb	Active
Spot-Check Monitor	PC-102	EUDAMED	Class IIa	Active
Multi Parameter monitors for Capnography and Pulse oximetry	PC-900B	EUDAMED	Class IIb	Active
Wrist Oximeter	AP-10	EUDAMED	Class IIa	Active
Vital Signs Minotor	LeMonitor VS	EUDAMED	Class IIb	Active
Sleep Screener	AP-20	EUDAMED	Class IIa	Active
Wrist Oximeter	PC-68B	EUDAMED	Class IIa	Active
Central Monitoring System	PC-1000A	EUDAMED	Class IIb	Active
Pulse Oximeter	Prince-100F	FDA UDI	Class II	Active
Pulse Oximeter	S5B	FDA UDI	Class II	Active
Pulse Oximeter	KS-60FW	FDA UDI	Class II	Active
Pulse Oximeter	S5G	FDA UDI	Class II	Active
Pulse Oximeter	PC-60C2	FDA UDI	Class II	Active
All-in-One Health Monitor	PC-303	EUDAMEDFDA UDI	Class II	Active
Pulse Oximeter	KS-60NW	FDA UDI	Class II	Active
Pulse Oximeter	PC-60F	FDA UDI	Class II	Active
Pulse Oximeter	S5WB	FDA UDI	Class II	Active
Pulse Oximeter	S5WG	FDA UDI	Class II	Active
Pulse Oximeter	PC-60C	FDA UDI	Class II	Active
Pulse Oximeter	KS-60FB	FDA UDI	Class II	Active
Pulse Oximeter	POD-1	FDA UDI	Class II	Active
Pulse Oximeter	KW-68B	FDA UDI	Class II	Active
Pulse Oximeter	S5	FDA UDI	Class II	Active
Pulse Oximeter	PC-66H	FDA UDI	Class II	Active
Pulse Oximeter	S5W	FDA UDI	Class II	Active
Pulse Oximeter	POD-3	FDA UDI	Class II	Active
Pulse Oximeter	KS-2	FDA UDI	Class II	Active
Pulse Oximeter	PC-60FW	FDA UDI	Class II	Active
Pulse Oximeter	PC-60E	FDA UDI	Class II	Active
Pulse Oximeter	PC-60NW	FDA UDI	Class II	Active
Pulse Oximeter	PC-60N	FDA UDI	Class II	Active
Pulse Oximeter	KS-60F	FDA UDI	Class II	Active
Pulse Oximeter	PC-60D2	FDA UDI	Class II	Active
Pulse Oximeter	PC-66L	FDA UDI	Class II	Active
Pulse Oximeter	KS-60NWB	FDA UDI	Class II	Active
Pulse Oximeter	KS-60FWB	FDA UDI	Class II	Active
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1	K150093	FDA 510(k)	Class II	Active
Handheld Pulse Oximeter, Model SP-20	K172792	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Model Pc-860 Fetal Doppler	K082055	FDA 510(k)	Class II	Active
Patient Monitor	K192343	FDA 510(k)	Class II	Active
Pc-180 / Prince 180 Easy Ecg Monitor	K073152	FDA 510(k)	Class II	Active
Pc-60, Non-Invasivepulse Oximeter	K063641	FDA 510(k)	Class II	Active
Pc-60nw Fingertip Oximeter	K120502	FDA 510(k)	Class II	Active
Pulse Oximeter	K201468	FDA 510(k)	Class II	Active
Patient Monitor	K123711	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
All-in-One Health Monitor, PC-303	K170047	FDA 510(k)	Class II	Active
Vital Signs Monitor	K093016	FDA 510(k)	Class II	Active
Easy ECG Monitor	PC-80B	EUDAMEDFDA UDI	Class IIa	Active

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