Manufacturer

Himaging

ChinaLegal entities : Himaging Technology (Shanghai) Co., Ltd.

Markets : Belgium · Iceland · Ireland · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 1 · class II · latest in 2025 · see on the FDA website

EU representative : Lotus NL B.V. (Netherlands)

5 categories, 7 models including 7 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Video bronchoscopes	Z12020802	Single-Use Flexible Video Bronchoscope DBRS-100HLP Single-Use Flexible Video Bronchoscope DBRS2-001P, DBRS2-121P, DBRS2-221P, DBRS2-301P, DBRS2-222HP, DBRS2-302HP, DBRS2-122HP, DBRS2-223HP, DBRS2-303HP, DBRS2-123HP3 refs	IIa MDR	EUDAMED record Report an error
Video cystourethroscopes	Z12020711	Single-Use Flexible Video Cystoscope DCYS-100HLP, DCYS-100HLPR2 refs Single-Use Flexible Video Cystoscope DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR3 refs	IIa MDR	EUDAMED record Report an error
Ureterorenoscopes	Z12020713	Single-use Flexible Video Ureterorenoscope DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRS3 refs	IIa MDR	EUDAMED record Report an error
Video nasopharyngo/laryngoscopes	Z12021006	Single-use Flexible Video Rhino-Laryngoscope DRLS-100HLP, DRLS2-222HP, DRLS2-223HP3 refs	IIa MDR	EUDAMED record Report an error
Video processors	Z12020406	Endoscopic video processor HDIS-1000	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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