Manufacturer

Shenzhen Changkun Technology

ChinaLegal entities : Shenzhen Changkun Technology Co., Ltd.

Markets : Germany · United States

Approvals : EU – class IIa · United States (FDA) – 510(k) : 7 · class I, II · latest in 2026 · see on the FDA website

EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)

2 categories, 23 models including 23 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Non-invasive oscillometric blood pressure gauges	Z1203020501	CHANGKUN CK-101S93/42 CHANGKUN CK-102S93/42 CHANGKUN CK-A12093/42 CHANGKUN CK-A13693/42 CHANGKUN CK-A13893/42 15 others CHANGKUN CK-A13993/42 CHANGKUN CK-A15593/42 CHANGKUN CK-A15693/42 CHANGKUN CK-A15893/42 CHANGKUN CK-A16893/42 CHANGKUN CK-W11893/42 CHANGKUN CK-W13293/42 CHANGKUN CK-W13393/42 CHANGKUN CK-W13593/42 CHANGKUN CK-W17593/42 CHANGKUN CK-W17693/42 CHANGKUN CK-W35593/42 CHANGKUN CK-W35693/42 CHANGKUN CK-W35893/42 Z1203020501 CK-10193/42	IIa 93/42	EUDAMED record Report an error
Non-contact digital thermometers	V0301010202	CHANGKUN CK-T150193/42 CHANGKUN CK-T150293/42 CHANGKUN CK-T150393/42	IIa 93/42	EUDAMED record Report an error

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