Question 1

What types of medical devices does Shandong Chenxing Medical Technology Co., Ltd. manufacture?

Accepted Answer

Shandong Chenxing Medical Technology Co., Ltd. specializes in manufacturing ostomy bags. These are medical devices designed to collect waste from a stoma, which is an artificial opening created in the abdomen for patients with colostomies or ileostomies. The company’s portfolio includes both disposable and reusable ostomy bags, tailored to meet various patient needs and clinical requirements.

Question 2

Where is Shandong Chenxing Medical Technology Co., Ltd. based?

Accepted Answer

The company is headquartered in China. While its primary market focus includes the European Union, the manufacturer operates from its base in Shandong Province, China, ensuring its products meet regulatory standards for global distribution.

Question 3

Which regulatory registries list Shandong Chenxing Medical Technology Co., Ltd.’s devices?

Accepted Answer

Shandong Chenxing Medical Technology Co., Ltd.’s ostomy bags are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices marketed within the EU, ensuring transparency and traceability under the Medical Device Regulation (MDR).

Question 4

How are Shandong Chenxing Medical Technology Co., Ltd.’s ostomy bags classified under EU regulations?

Accepted Answer

The company’s ostomy bags fall under Class I classification in the EU. This classification is assigned based on the risk associated with the device, and Class I devices are generally considered low-risk, requiring compliance with basic safety and performance requirements. Registration in EUDAMED reflects this classification.

Device	Model / Reference	Registries	Class	Status
Ostomy bag	C1G605	EUDAMED	Class I	Active
Ostomy bag	N2G602	EUDAMED	Class I	Active
Ostomy bag	N2T553	EUDAMED	Class I	Active
Ostomy bag	C2G603	EUDAMED	Class I	Active
Ostomy bag	N1S704	EUDAMED	Class I	Active
Ostomy bag	C1T705	EUDAMED	Class I	Active
Ostomy bag	N1G603	EUDAMED	Class I	Active
Ostomy bag	C1S804	EUDAMED	Class I	Active
Ostomy bag	C1B705	EUDAMED	Class I	Active
Ostomy bag	N1B701	EUDAMED	Class I	Active
Ostomy bag	C2G702	EUDAMED	Class I	Active
Ostomy bag	N2S603	EUDAMED	Class I	Active
Ostomy bag	C2G602	EUDAMED	Class I	Active
Ostomy bag	C1B604	EUDAMED	Class I	Active
Ostomy bag	N2S703	EUDAMED	Class I	Active
Ostomy bag	N2T351	EUDAMED	Class I	Active
Ostomy bag	C1G604	EUDAMED	Class I	Active
Ostomy bag	N2S601	EUDAMED	Class I	Active
Ostomy bag	C1S805	EUDAMED	Class I	Active
Ostomy bag	N1S605	EUDAMED	Class I	Active
Ostomy bag	N1G602	EUDAMED	Class I	Active
Ostomy bag	C2B703	EUDAMED	Class I	Active
Ostomy bag	N1G604	EUDAMED	Class I	Active
Ostomy bag	N1B704	EUDAMED	Class I	Active
Ostomy bag	C1Y602	EUDAMED	Class I	Active
Ostomy bag	N2S501	EUDAMED	Class I	Active
Ostomy bag	C1S1003	EUDAMED	Class I	Active
Ostomy bag	N2T552	EUDAMED	Class I	Active
Ostomy bag	C2S602	EUDAMED	Class I	Active
Ostomy bag	N1T551	EUDAMED	Class I	Active
Ostomy bag	C1T553	EUDAMED	Class I	Active
Ostomy bag	N1S604	EUDAMED	Class I	Active
Ostomy bag	N1S801	EUDAMED	Class I	Active
Ostomy bag	N1Y601	EUDAMED	Class I	Active
Ostomy bag	N1S701	EUDAMED	Class I	Active
Ostomy bag	N1S1001	EUDAMED	Class I	Active
Ostomy bag	N1G601	EUDAMED	Class I	Active

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