Question 1

What types of medical devices does Danyang Sunco Machinery Co.Ltd manufacture?

Accepted Answer

Danyang Sunco Machinery Co.Ltd specializes in mobility assistance devices, including non-foldable walking chairs, rollators, electric wheelchairs, electric scooters, and power packs. These products are designed to support individuals with limited mobility, providing stability and independence in movement.

Question 2

Where is Danyang Sunco Machinery Co.Ltd based?

Accepted Answer

The company is headquartered in China. While the specific location within the country is not provided, its primary focus is on manufacturing mobility devices tailored for global markets.

Question 3

Which regulatory registries list the devices made by Danyang Sunco Machinery Co.Ltd?

Accepted Answer

The devices produced by Danyang Sunco Machinery Co.Ltd are listed in the eudamed registry, which is the EU’s central database for medical devices. This registry tracks devices authorized for placement on the European market, ensuring transparency and traceability.

Question 4

How are the devices manufactured by Danyang Sunco Machinery Co.Ltd classified?

Accepted Answer

The company’s devices fall under Class I classification, which typically includes low-risk medical devices such as mobility aids like rollators, walking chairs, and power packs. Classification is determined by risk assessment criteria, and Class I devices generally require fewer regulatory controls than higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Wheelchair	SKW8058	EUDAMED	Class I	Active
Wheelchair	SKW8070	EUDAMED	Class I	Active
Rollator	SKW3006	EUDAMED	Class I	Active
Wheelchair	SKW9056	EUDAMED	Class I	Active
Wheelchair	SKW8005	EUDAMED	Class I	Active
Wheelchair	SKW9043	EUDAMED	Class I	Active
Wheelchair	SKW9008	EUDAMED	Class I	Active
Wheelchair	SKW9048	EUDAMED	Class I	Active
Wheelchair	SKW9028	EUDAMED	Class I	Active
Wheelchair	SKW8024	EUDAMED	Class I	Active
Rollator	SKW3009	EUDAMED	Class I	Active
Wheelchair	SKW9031	EUDAMED	Class I	Active
Wheelchair	SKW8038	EUDAMED	Class I	Active
Wheelchair	SKW9078	EUDAMED	Class I	Active
Wheelchair	SKW8002D	EUDAMED	Class I	Active
Wheelchair	SKW8045	EUDAMED	Class I	Active
Wheelchair	SKW9005	EUDAMED	Class I	Active
Wheelchair	SKW9026	EUDAMED	Class I	Active
Wheelchair	SKW9072	EUDAMED	Class I	Active
Wheelchair	SKW8001-12	EUDAMED	Class I	Active
Wheelchair	SKW8075	EUDAMED	Class I	Active
Wheelchair	SKW8069	EUDAMED	Class I	Active
Wheelchair	SKW9049	EUDAMED	Class I	Active
Wheelchair	SKW8025	EUDAMED	Class I	Active
Wheelchair	SKW8009	EUDAMED	Class I	Active
Wheelchair	SKW9068	EUDAMED	Class I	Active
Wheelchair	SKW8079	EUDAMED	Class I	Active
Wheelchair	SKW9032	EUDAMED	Class I	Active
Wheelchair	SKW8078	EUDAMED	Class I	Active
Rollator	SKW3002	EUDAMED	Class I	Active
Wheelchair	SKW8055	EUDAMED	Class I	Active
Wheelchair	SKW9008A	EUDAMED	Class I	Active
Wheelchair	SKW9061	EUDAMED	Class I	Active
Wheelchair	SKW8032	EUDAMED	Class I	Active
Wheelchair	SKW9069	EUDAMED	Class I	Active
Wheelchair	SKW9033	EUDAMED	Class I	Active
Rollator	SKW3005	EUDAMED	Class I	Active
Rollator	SKW3001	EUDAMED	Class I	Active
Wheelchair	SKW9066	EUDAMED	Class I	Active
Rollator	SKW3007	EUDAMED	Class I	Active
Wheelchair	SKW9074	EUDAMEDFDA 510(k)	Class I	Active

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