Question 1

What types of medical devices does Jiangsu Saikang Medical Equipment Co., Ltd. primarily manufacture?

Accepted Answer

Jiangsu Saikang Medical Equipment Co., Ltd. specializes in producing basic hospital beds, including electric hospital beds and treatment beds. Their portfolio also includes supporting medical furniture such as medical chairs, bedside tables, and medical trolleys, as well as clinical equipment like X-ray film viewers and operating lamps. These devices are designed for use in hospitals, rehabilitation centers, and home care settings.

Question 2

Where is Jiangsu Saikang Medical Equipment Co., Ltd. based?

Accepted Answer

The company is headquartered in China, specifically in Jiangsu province. This geographic location influences its regulatory compliance requirements, particularly for devices intended for markets like the EU.

Question 3

How are Jiangsu Saikang Medical Equipment Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Jiangsu Saikang Medical Equipment Co., Ltd.’s devices fall under Class I classification in the EU regulatory framework. This classification applies to low-risk medical devices, such as basic hospital beds, medical chairs, and bedside tables, which do not require stringent pre-market clinical evaluations but still must comply with essential safety and performance requirements.

Question 4

Are Jiangsu Saikang Medical Equipment Co., Ltd.’s devices listed in any regulatory databases?

Accepted Answer

Yes, Jiangsu Saikang Medical Equipment Co., Ltd.’s devices are listed in the EUDAQS database (eudamed), which is the official EU registry for medical devices. Listing in eudamed ensures transparency and traceability for authorized devices marketed within the European Economic Area.

Device	Model / Reference	Registries	Class	Status
Electric Operating Table	A100-4	EUDAMED	Class I	Active
Medical Chair	SKE020-1	EUDAMED	Class I	Active
Electric Hospital Bed	CQ8k	EUDAMED	Class I	Active
Medical Trolley	SKH041-4	EUDAMED	Class I	Active
Medical Trolley	SKR002-3	EUDAMED	Class I	Active
Stretcher	SKB1C10	EUDAMED	Class I	Active
Bedside Table	SKS003	EUDAMED	Class I	Active
Mattress	SKP006	EUDAMED	Class I	Active
Stretcher	SKB037(A)	EUDAMED	Class I	Active
Medical Trolley	SKH040-1	EUDAMED	Class I	Active
Medical Trolley	SKR058-ET	EUDAMED	Class I	Active
Stretcher	SKB1C01-1	EUDAMED	Class I	Active
Mattress	SKP008	EUDAMED	Class I	Active
Medical Trolley	SKR-ET625	EUDAMED	Class I	Active
Medical Trolley	SKR-CT625-1	EUDAMED	Class I	Active
Tilting Table	SK-ZL05	EUDAMED	Class I	Active
Bedside Table	SKH042	EUDAMED	Class I	Active
Medical Trolley	SKR051-ET	EUDAMED	Class I	Active
Medical Chair	SKE-141	EUDAMED	Class I	Active
Medical Chair	SKE060	EUDAMED	Class I	Active
Tilting Table	SK-ZL03	EUDAMED	Class I	Active
Medical Trolley	SKR-MT625	EUDAMED	Class I	Active
Medical Trolley	SKR054-AT	EUDAMED	Class I	Active
Electric Hospital Bed	D6d	EUDAMED	Class I	Active
Bedside Table	SKH091	EUDAMED	Class I	Active
Bedside Table	SKS002	EUDAMED	Class I	Active
Medical Trolley	SKH006-1	EUDAMED	Class I	Active
Bedside Table	SKS025	EUDAMED	Class I	Active
Medical Trolley	SKH006-5	EUDAMED	Class I	Active
Instrument Trolley	SKH007-1S	EUDAMED	Class I	Active
Medical Trolley	SKR-AT670	EUDAMED	Class I	Active
Medical Chair	SKE015-5	EUDAMED	Class I	Active
Hospital Bed Accessories	IV Stand SKH041(1)	EUDAMED	Class I	Active
StepStool	SKE020-1D	EUDAMED	Class I	Active
Electric Hospital Bed	X36	EUDAMED	Class I	Active
Stretcher	SKB041-1	EUDAMED	Class I	Active
Dental Unit	SDL-C0238	EUDAMED	Class I	Active
Bedside Table	SKH046-11	EUDAMED	Class I	Active
StepStool	SKE020-3	EUDAMED	Class I	Active
Operating Lamp	AInno Light 10	EUDAMED	Class I	Active
Stretcher	SKB1A01	EUDAMED	Class I	Active
Medical Trolley	SKR-CT600	EUDAMED	Class I	Active
Medical Trolley	SKH049	EUDAMED	Class I	Active
Manual Hospital Bed	SK005-10H	EUDAMED	Class I	Active
Manual Hospital Bed	R105W	EUDAMED	Class I	Active
Stretcher	SKB1C02-1	EUDAMED	Class I	Active
Medical Screen	SKH049-7	EUDAMED	Class I	Active
Traction Bed	SKY-IV	EUDAMED	Class I	Active
Hospital Bed Accessories	K23-1	EUDAMED	Class I	Active
Medical Trolley	SKR-B00	EUDAMED	Class I	Active

Jiangsu Saikang Medical Equipment Co.,Ltd

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