Manufacturer

Shanghai Handy Medical Equipment

ChinaLegal entities : Shanghai Handy Medical Equipment Co., Ltd.

Markets : Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 1 · class I, II · latest in 2022 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

4 categories, 4 models including 4 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Equipment for conventional endoral radiology	Z1103040101	Dental X-ray Unit HDX-7030, HDX-7020, HDX-6520, HDX-60303 refs	IIb MDR	EUDAMED record Report an error
Equipment for digital endoral radiology	Z1103040102	Digital Dental X-ray Imaging System HDR-500, HDR-500A, HDR-500B, HDR-500C, HDR-600, HDR-600A, HDR-600B, HDR-600C, HDR-360, HDR-460, HDR-380, HDR-490, HDR-330, HDR-4803 refs	IIa MDR	EUDAMED record Report an error
Photo cameras	Z11039010	Intraoral Camera HDI-712D, HDI-712C, HDI-712B, HDI-220D, HDI-220C, HDI-220B, HDI-210, HDI-200A, HDI-100A3 refs	I MDR	EUDAMED record Report an error
Single-input computed radiography (cr) systems	Z11060201	Digital Imaging Plate Scanner HDS-500	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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