Question 1

What does OriGyn Medical Technology (Hangzhou) Co., Ltd. make?

Accepted Answer

OriGyn Medical Technology (Hangzhou) Co., Ltd. makes reusable rigid endoscopic tissue manipulation forceps, reusable rigid endoscopic scissors, and rigid video hysteroscopes. These are surgical instruments used in minimally invasive procedures for tissue handling, cutting, and visualization within the uterine cavity.

Question 2

Where is OriGyn Medical Technology (Hangzhou) Co., Ltd. based?

Accepted Answer

OriGyn Medical Technology (Hangzhou) Co., Ltd. is based in the United States, as stated in the provided summary information about the company's location.

Question 3

Which registries list OriGyn Medical Technology (Hangzhou) Co., Ltd.'s devices?

Accepted Answer

OriGyn Medical Technology (Hangzhou) Co., Ltd.'s devices are listed in the FDA 510(k) database and the FDA UDI system, as indicated in the LISTED IN field and confirmed in the summary section of the device data.

Question 4

How are OriGyn Medical Technology (Hangzhou) Co., Ltd.'s devices classified?

Accepted Answer

OriGyn Medical Technology (Hangzhou) Co., Ltd.'s devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field and reiterated in the summary which states the classification levels for the company's products.

Device	Model / Reference	Registries	Class	Status
OriGynMED	YZ211.071	FDA UDI	Class I	Active
OriGynMED	YZ211.085	FDA UDI	Class I	Active
OriGynMED	YZ211.077	FDA UDI	Class I	Active
OriGynMED	YZ211.053	FDA UDI	Class I	Active
OriGynMED	YZ211.043	FDA UDI	Class I	Active
OriGynMED	YZ211.074	FDA UDI	Class I	Active
OriGynMED	YZ211.042	FDA UDI	Class I	Active
ClearVision	EHS-Op5001	FDA UDI	Class II	Active
OriGynMED	YZ211.122	FDA UDI	Class I	Active
OriGynMED	YZ211.057	FDA UDI	Class I	Active
OriGynMED	YZ211.041	FDA UDI	Class I	Active
OriGynMED	YZ211.086	FDA UDI	Class I	Active
OriGynMED	YZ211.075	FDA UDI	Class I	Active
OriGynMED	YZ211.046	FDA UDI	Class I	Active
OriGynMED	YZ211.073	FDA UDI	Class I	Active
ClearVision	EHS-Op6001	FDA UDI	Class II	Active
OriGynMED	YZ211.123	FDA UDI	Class I	Active
OriGynMED	YZ211.124	FDA UDI	Class I	Active
OriGynMED	YZ211.045	FDA UDI	Class I	Active
OriGynMED	YZ211.056	FDA UDI	Class I	Active
ClearVision	EHS-Dx4001	FDA UDI	Class II	Active
OriGynMED	YZ211.054	FDA UDI	Class I	Active
OriGynMED	YZ211.113	FDA UDI	Class I	Active
OriGynMED	YZ211.047	FDA UDI	Class I	Active
OriGynMED	YZ211.076	FDA UDI	Class I	Active
OriGynMED	YZ211.087	FDA UDI	Class I	Active
OriGynMED	YZ211.072	FDA UDI	Class I	Active
OriGynMED	YZ211.052	FDA UDI	Class I	Active
OriGynMED	YZ211.111	FDA UDI	Class I	Active
OriGynMED	YZ211.082	FDA UDI	Class I	Active
OriGynMED	YZ211.112	FDA UDI	Class I	Active
OriGynMED	YZ211.121	FDA UDI	Class I	Active
OriGynMED	YZ211.083	FDA UDI	Class I	Active
OriGynMED	YZ211.114	FDA UDI	Class I	Active
ClearVision	EHS-IPS01US	FDA UDI	Class II	Active
OriGynMED	YZ211.044	FDA UDI	Class I	Active
OriGynMED	YZ211.081	FDA UDI	Class I	Active
OriGynMED	YZ211.084	FDA UDI	Class I	Active
OriGynMED	YZ211.055	FDA UDI	Class I	Active
OriGynMED	YZ211.051	FDA UDI	Class I	Active
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)	K240401	FDA 510(k)	Class II	Active

OriGyn Medical Technology (Hangzhou) Co., Ltd.

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