Question 1

What types of medical devices does Zhejiang Nysin Medical Co., Ltd. manufacture?

Accepted Answer

Zhejiang Nysin Medical Co., Ltd. specializes in mobility aids, primarily focusing on non-foldable walking chairs, electric scooters, rollators, and powered wheelchairs. Their product line includes models like the NXN20-205, NXN20-208, and NXN20-211, as well as electric wheelchairs and power wheelchairs designed to assist individuals with limited mobility.

Question 2

Where is Zhejiang Nysin Medical Co., Ltd. based?

Accepted Answer

The company is headquartered in China, specifically in Zhejiang province, as indicated by its name and registration details.

Question 3

Which regulatory registries list Zhejiang Nysin Medical Co., Ltd.’s devices?

Accepted Answer

The company’s devices are listed in the EU’s EUDAMED database and the FDA’s 510(k) registry, meaning their products are tracked under these regulatory frameworks for compliance and transparency.

Question 4

How are Zhejiang Nysin Medical Co., Ltd.’s devices classified under medical device regulations?

Accepted Answer

The company’s devices fall under Class I and Class II classifications, which determine regulatory oversight levels. Class I devices typically pose minimal risk and require basic compliance, while Class II devices involve moderate risk and require additional validation or performance standards.

Device	Model / Reference	Registries	Class	Status
Electric Wheelchair	NXW30-107	EUDAMED	Class I	Active
Electric Wheelchair	NXW25-226	EUDAMED	Class I	Active
Power Wheelchair	NXN20-209	EUDAMEDFDA UDI	Class I	Active
Electric Wheelchair	NXN18-208CA	EUDAMED	Class I	Active
Electric Wheelchair	NXN20-227	EUDAMED	Class I	Active
Electric Scooter	DDF110	EUDAMED	Class I	Active
Electric Scooters	DDT078	EUDAMED	Class I	Active
Electric Wheelchair	NXN20-208	EUDAMED	Class I	Active
Electric Wheelchair	NXW25-119	EUDAMED	Class I	Active
Electric Wheelchair	NXW25-108	EUDAMED	Class I	Active
Electric Wheelchair	NXN20-216	EUDAMED	Class I	Active
Electric Scooter	DDF104	EUDAMED	Class I	Active
Electric Scooter	DDF107	EUDAMED	Class I	Active
Electric Scooters	DDT077	EUDAMED	Class I	Active
Electric Wheelchair	NXW25-220	EUDAMED	Class I	Active
Power Wheelchair	NXN20-211	EUDAMED	Class I	Active
Electric Wheelchair	NXW20-219	EUDAMED	Class I	Active
Electric Scooter	DDF103	EUDAMED	Class I	Active
Electric Wheelchair	NXW25-203AF	EUDAMED	Class I	Active
Electric Scooters	ST097	EUDAMED	Class I	Active
Electric Wheelchair	NXN20-217	EUDAMED	Class I	Active
Electric Wheelchair	NXW20-218	EUDAMED	Class I	Active

ZHEJIANG NYSIN MEDICAL CO., LTD.

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