Question 1

What does Hansol Medical Co. manufacture?

Accepted Answer

Hansol Medical Co. specializes in manufacturing cupping therapy devices, including models such as AG PROFESSIONAL and ACUDEPOT. These devices are designed for therapeutic cupping applications.

Question 2

Where is Hansol Medical Co. based?

Accepted Answer

Hansol Medical Co. is based in South Korea, as indicated by the country code KR in the device data. The company operates from this location to produce and distribute its medical devices.

Question 3

Which regulatory registries list Hansol Medical Co.'s devices?

Accepted Answer

Hansol Medical Co.'s devices are listed in the EU's EUDAMED registry and the FDA UDI registry. These listings help track and identify the company's medical devices in their respective markets.

Question 4

How are Hansol Medical Co.'s devices classified?

Accepted Answer

Hansol Medical Co.'s devices are classified as Class I and Class IIa medical devices. Class I devices are low-risk, while Class IIa devices have moderate risk, both requiring different levels of regulatory control.

Device	Model / Reference	Registries	Class	Status
Sterile single-use acupuncture needle	0.30*90	EUDAMEDFDA UDI	Class IIa	Active
Sterile Disposable Acupuncture Needle	Sterile Disposable Acupuncture Needle	EUDAMED	Class IIa	Active
Sterile single-use acupuncture needle	0.35*60	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.40*105	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.35*40	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.20*120	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.40*30	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.35*105	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.20*60	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.35*30	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.25*15	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.20*30	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.40*50	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.25*60	EUDAMEDFDA UDI	Class IIa	Active
Sterile single-use acupuncture needle	0.30*15	EUDAMEDFDA UDI	Class IIa	Active

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