Question 1

What types of medical devices does APK Technology Co., Ltd. manufacture?

Accepted Answer

APK Technology Co., Ltd. specializes in manufacturing medical accessories for patient monitoring and therapeutic use. Their product line includes disposable and reusable ECG cables, temperature probes, pulse oximeter sensors (both reusable and disposable), ECG disposable lead wires, and ultraviolet phototherapy devices. These devices are designed to support critical monitoring and treatment functions in clinical settings.

Question 2

Where is APK Technology Co., Ltd. based?

Accepted Answer

APK Technology Co., Ltd. is headquartered in China. The company’s manufacturing focus aligns with its location, producing medical accessories tailored for global patient monitoring and therapeutic applications.

Question 3

Which regulatory registries list APK Technology Co., Ltd.’s devices?

Accepted Answer

APK Technology Co., Ltd.’s devices are listed in the EU’s eudamed registry and the FDA’s 510(k) database. These registries track medical devices that have undergone the necessary regulatory processes for market authorization in their respective regions.

Question 4

How are APK Technology Co., Ltd.’s devices classified under medical device regulations?

Accepted Answer

APK Technology Co., Ltd.’s devices fall under Class I and Class II classifications. Class I devices typically pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and require additional validation to ensure safety and performance. The classification determines the regulatory scrutiny and authorization requirements for each product.

Device	Model / Reference	Registries	Class	Status
ECG Cables	A42HEC10IK	EUDAMED	Class I	Active
ECG Cables	A3009-EK1A	EUDAMED	Class I	Active
ECG Cables	A5456-EC1	EUDAMED	Class I	Active
ECG Cables	A6457-EL1	EUDAMED	Class I	Active
ECG Cables	A6197-EL1	EUDAMED	Class I	Active
Temperature Probes	MDR	EUDAMED	Class I	Active
Temperature Probes	A-TP-12	EUDAMED	Class I	Active
Temperature probe	A-TP-06	EUDAMED	Class I	Active
Apk Spo2 Pulse Oximeter Sensor	K082846	FDA 510(k)	Class II	Active
Reusable SpO2 Sensors, Disposable SpO2 Sensors	K172981	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
ECG Disposable Lead Wire	K170536	FDA 510(k)	Class II	Active
Ultraviolet Phototherapy Device	K250425	FDA 510(k)	Class II	Active
Disposable Temperature probe	A-DDR-03-01	EUDAMED	Class I	Active
Temperature probe	A-GE-07	EUDAMED	Class I	Active
Disposable Temperature probe	A-DOM-01-01	EUDAMED	Class I	Active
Temperature probe	A-TP-05	EUDAMED	Class I	Active
SpO2 Extension Cable	A0209-C02	EUDAMED	Class I	Active
Temperature probe	A-SS-06	EUDAMED	Class I	Active
Temperature Probes	A-MR-01	EUDAMED	Class I	Active
Disposable Temperature probe	A-DOM-01-02	EUDAMED	Class I	Active
Temperature probe	A-MR-06	EUDAMED	Class I	Active
Temperature probe	A-GE-01-02	EUDAMED	Class I	Active
ECG Disposable Lead wires	A0001D03	EUDAMEDFDA UDI	Class I	Active
Temperature probe	A-LB-01	EUDAMED	Class I	Active
Disposable Temperature probe	A-DOM-03-01	EUDAMED	Class I	Active
Temperature Probes	A-MR-03	EUDAMED	Class I	Active
Disposable Temperature probe	A-DOM-02	EUDAMED	Class I	Active
Temperature probe	A-GE-03	EUDAMED	Class I	Active
Temperature Probes	MDR	EUDAMED	Class I	Active
Temperature probe	A-HP-06	EUDAMED	Class I	Active
Temperature Probe	A-CM-03	EUDAMED	Class I	Active
Temperature probe	A-LB-03	EUDAMED	Class I	Active
Disposable Temperature probe	A-DYS-02	EUDAMED	Class I	Active
Blood pressure cuff	A-XT-01	EUDAMEDFDA UDI	Class I	Active
Temperature probe	A-GE-01	EUDAMED	Class I	Active
Temperature Probes	A-TP-13	EUDAMED	Class I	Active
Disposable Temperature probe	A-DOM-03	EUDAMED	Class I	Active
Temperature probe	A-SL-03	EUDAMED	Class I	Active

APK Technology Co., Ltd.

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