Manufacturer

Runyes

ChinaLegal entities : Ningbo Runyes Medical Instrument Co., Ltd.

First countries of placing on the market declared in EUDAMED : Croatia, Germany, Hungary, Netherlands, Türkiye

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

8 categories, 26 models including 26 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Equipment for conventional endoral radiology	Z1103040101	POCT22, SUPER05, XR(G)2 refs RAY68(M),RAY68(W), XR(M), XR(W)2 refs RAY98(M) RAY98(W), XR98(M), XR98(W)2 refs RAY98(P), XR(P) YOU(M),YOU(W)2 refs 2 others YOU(MG), YOU(WG)2 refs YOU98(P)	IIb MDR	EUDAMED record Report an error
Small load autoclaves with a chamber smaller than 1 standard sterilisation unit	Z12011305	BES23L,BES18L,BES16L,BES12L, BES8L3 refs BES45L,BES29L2 refs CAL45L SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L3 refs SEA29L,CAL29L 2 others SEA45L STE5L, BES5L, CAL5L3 refs	IIa MDR	EUDAMED record Report an error
Dental treatment units	Z12110101	Care-22 Care-33, Ease-03, Care-883 refs Ease-02 Maple 42D, Maple 42U2 refs Maple 62D,Maple 62U2 refs	IIa MDR	EUDAMED record Report an error
Bioimaging photography instruments	Z119003	iGrapher IOS-11, 3DS Mega, 3DS Ultra, SCAN11, SCAN-i5, SCAN-i6, SCAN33, SCAN-V5, SCAN-V6, ORAL-O3, SCAN-O5, SCAN-O63 refs	I MDR	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	DR730 ,DR7502 refs US980, US9902 refs	IIa MDR	EUDAMED record Report an error
Electric medical chairs - other	V08020199	Care-11，Ease-012 refs	IIa MDR	EUDAMED record Report an error
Single-input computed radiography (cr) systems	Z11060201	DS830, DS630	I MDR	EUDAMED record Report an error
Various dental stomatology instruments - hardware accessories	Z12119080	FAS-S、FAS-M、FAS-L、FAS-X	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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