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.

SHANGHAI HUMANCARE INDUSTRIES CO.,LTD

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Device	Model / Reference	Registries	Class	Status
Rollator	hc0514-1	EUDAMED	Class I	Active
Rollator	HC0517LG-44	EUDAMED	Class I	Active
commode chair	HC6712	EUDAMED	Class I	Active
Wheelchair	HC8301	EUDAMED	Class I	Active
Wheelchair	HC865H	EUDAMED	Class I	Active
shower chair	HC251LS	EUDAMED	Class I	Active
shower chair	HC244L	EUDAMED	Class I	Active
commode chair	HC6531	EUDAMED	Class I	Active
Rollator	HC0508L	EUDAMED	Class I	Active
Wheelchair	HC9801Q	EUDAMED	Class I	Active
commode chair	HC0670L	EUDAMED	Class I	Active
commode chair	HC0693	EUDAMED	Class I	Active
Wheelchair	HC8952	EUDAMED	Class I	Active
commode chair	HC6750	EUDAMED	Class I	Active
commode chair	HC0607	EUDAMED	Class I	Active
Rollator	HC051LW	EUDAMED	Class I	Active
Rollator	HC0566	EUDAMED	Class I	Active
Wheelchair	HC8932B	EUDAMED	Class I	Active
commode chair	HC6758	EUDAMED	Class I	Active
commode chair	HC0677	EUDAMED	Class I	Active
commode chair	HC0611U	EUDAMED	Class I	Active
commode chair	HC0668	EUDAMED	Class I	Active
Rollator	HC0544L-3	EUDAMED	Class I	Active
Rollator	HC0543L	EUDAMED	Class I	Active
shower chair	HC262L	EUDAMED	Class I	Active
commode chair	HC616S	EUDAMED	Class I	Active
shower chair	HC2362U	EUDAMED	Class I	Active
Rollator	HC055L	EUDAMED	Class I	Active
shower chair	HC2581L	EUDAMED	Class I	Active
Wheelchair	HC8913	EUDAMED	Class I	Active
shower chair	HC2741	EUDAMED	Class I	Active