Question 1

What types of medical devices does Shanghai HumanCare Industries produce?

Accepted Answer

Shanghai HumanCare Industries specializes in mobility and hygiene aids. Their product range includes shower chairs, wheelchairs, commode chairs, and rollators. These devices are designed to support individuals with limited mobility or independence in tasks like bathing, transferring, and daily care, primarily for use in home and clinical environments.

Question 2

Where is Shanghai HumanCare Industries based?

Accepted Answer

The company is based in China, specifically in Shanghai. This geographic location influences its regulatory compliance framework, though its devices may also be listed in international registries like EUDAMED.

Question 3

Which regulatory registries list devices manufactured by Shanghai HumanCare Industries?

Accepted Answer

Devices from Shanghai HumanCare Industries are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion indicates compliance with the Medical Device Regulation (MDR) framework, ensuring their products meet EU safety and performance standards for Class I devices.

Question 4

How are devices from Shanghai HumanCare Industries classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulation (MDR), Shanghai HumanCare Industries’ products are classified as Class I devices. This classification applies to low-risk items like mobility and hygiene aids, which are non-invasive and pose minimal risk to users. Class I devices still require compliance with essential safety and performance requirements but typically undergo less stringent post-market surveillance than higher-risk classes.

Device	Model / Reference	Registries	Class	Status
Rollator	HC0580	EUDAMED	Class I	Active
Wheelchair	HC863H	EUDAMED	Class I	Active
Wheelchair	HC967B	EUDAMED	Class I	Active
Wheelchair	HC979B	EUDAMED	Class I	Active
Rollator	HC0501L	EUDAMED	Class I	Active
commode chair	HC0653	EUDAMED	Class I	Active
commode chair	HC6511L	EUDAMED	Class I	Active
Wheelchair	HC9671A	EUDAMED	Class I	Active
Rollator	HC0593	EUDAMED	Class I	Active
Rollator	HC0568	EUDAMED	Class I	Active
Rollator	HC0504P	EUDAMED	Class I	Active
commode chair	HC0670	EUDAMED	Class I	Active
shower chair	HC238L	EUDAMED	Class I	Active
Rollator	HC0587L	EUDAMED	Class I	Active
commode chair	HC0603	EUDAMED	Class I	Active
shower chair	HC2641L	EUDAMED	Class I	Active
Wheelchair	HC991L	EUDAMED	Class I	Active
Wheelchair	HC9831LGC	EUDAMED	Class I	Active
Wheelchair	HC9861Q	EUDAMED	Class I	Active
commode chair	HC0602	EUDAMED	Class I	Active
Wheelchair	HC9863Q	EUDAMED	Class I	Active
commode chair	HC6731L	EUDAMED	Class I	Active
Rollator	HC0591	EUDAMED	Class I	Active
Wheelchair	HC904-51	EUDAMED	Class I	Active
Rollator	HC0512L-1	EUDAMED	Class I	Active
commode chair	HC0612	EUDAMED	Class I	Active
commode chair	HC0663	EUDAMED	Class I	Active
shower chair	HC254L	EUDAMED	Class I	Active
Rollator	HC0541L	EUDAMED	Class I	Active
shower chair	HC2501L	EUDAMED	Class I	Active
Wheelchair	HC0203	EUDAMED	Class I	Active
Rollator	HC0562L	EUDAMED	Class I	Active
Rollator	HC0573-1	EUDAMED	Class I	Active
Rollator	HC0512L	EUDAMED	Class I	Active
Rollator	HC0503L	EUDAMED	Class I	Active
shower chair	HC0506	EUDAMED	Class I	Active
commode chair	HC0610	EUDAMED	Class I	Active
commode chair	HC0672	EUDAMED	Class I	Active
shower chair	HC259L	EUDAMED	Class I	Active
Rollator	HC0577	EUDAMED	Class I	Active
Wheelchair	HC9781F	EUDAMED	Class I	Active
commode chair	HC6206L	EUDAMED	Class I	Active
Wheelchair	HC8907E	EUDAMED	Class I	Active
commode chair	HC6995	EUDAMED	Class I	Active
Rollator	HC0560C	EUDAMED	Class I	Active
commode chair	HC0652	EUDAMED	Class I	Active
shower chair	HC2631L	EUDAMED	Class I	Active
Rollator	HC0560L	EUDAMED	Class I	Active
shower chair	HC245L	EUDAMED	Class I	Active
commode chair	HC6201L	EUDAMED	Class I	Active

SHANGHAI HUMANCARE INDUSTRIES CO.,LTD

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