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
Medical Chair	SKE008	EUDAMED	Class I	Active
Medical Trolley	SKR-R10	EUDAMED	Class I	Active
X-ray Film Viewer	SK-L516	EUDAMED	Class I	Active
X-ray Film Viewer	SK-L513	EUDAMED	Class I	Active
Treatment Bed	SKY-I	EUDAMED	Class I	Active
Medical Chair	SKE-135	EUDAMED	Class I	Active
Medical Trolley	SKR-R03	EUDAMED	Class I	Active
Medical Trolley	SKR054-AT77A	EUDAMED	Class I	Active
Operating Lamp	AInno Light 20	EUDAMED	Class I	Active
Electric Hospital Bed	A6k	EUDAMED	Class I	Active
Medical Chair	SKE-136	EUDAMED	Class I	Active
Operating Lamp	SK-L315A	EUDAMED	Class I	Active
Bedside Table	SKH046-1	EUDAMED	Class I	Active
Operating Lamp	AInno Light 11	EUDAMED	Class I	Active
Medical Trolley	SKR-AB00	EUDAMED	Class I	Active
Electric Hospital Bed	SK-D08	EUDAMED	Class I	Active
Operating Lamp	AInno Light M	EUDAMED	Class I	Active
Medical Chair	SKE-195	EUDAMED	Class I	Active
Electric Hospital Bed	X15	EUDAMED	Class I	Active
Stretcher	SKB039(C)	EUDAMED	Class I	Active
Medical Trolley	SKR-CT232	EUDAMED	Class I	Active
Tilting Table	SKQ-11	EUDAMED	Class I	Active
Operating Lamp	SK-L306	EUDAMED	Class I	Active
Operating Lamp	AInno Light 21	EUDAMED	Class I	Active
Hospital Bed Accessories	IV Pole	EUDAMED	Class I	Active
Traction Bed	SKY-II	EUDAMED	Class I	Active
Electric Operating Table	A99-8	EUDAMED	Class I	Active
Manual Hospital Bed	D3w	EUDAMED	Class I	Active
Operating Lamp	SK-LLD7050A	EUDAMED	Class I	Active
Medical Trolley	SKH028	EUDAMED	Class I	Active
Stretcher	SKB041-3	EUDAMED	Class I	Active
Control Box	SKCB5	EUDAMED	Class I	Active
Instrument Trolley	SKH103	EUDAMED	Class I	Active
Medical Trolley	SKR058-NT	EUDAMED	Class I	Active
Medical Trolley	SKH002	EUDAMED	Class I	Active
Medical Chair	SKE087	EUDAMED	Class I	Active
Medical Chair	SKE-132	EUDAMED	Class I	Active
Medical Chair	SKE004-1	EUDAMED	Class I	Active
Instrument Trolley	SKH099	EUDAMED	Class I	Active
Operating Table	A045-1	EUDAMED	Class I	Active
StepStool	SKE020-2	EUDAMED	Class I	Active
Mattress	SKP041	EUDAMED	Class I	Active
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
Mattress	SKP006	EUDAMED	Class I	Active
Medical Trolley	SKH040-1	EUDAMED	Class I	Active
Medical Trolley	SKR058-ET	EUDAMED	Class I	Active

Jiangsu Saikang Medical Equipment Co.,Ltd

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