Manufacturer

Shinva

ChinaLegal entities : Shinva Medical Instrument Co., Ltd.

Markets : Croatia · Cyprus · Germany · Liechtenstein · Portugal · Romania · Slovakia · Slovenia · Spain · United States

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

EU representative : MedNet EC-REP C IIb GmbH (Germany)

13 categories, 15 models including 15 on the market, 1 country

Export to CSV

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Chemical sterilisation equipment	Z12011303	Ethylene Oxide Sterilizer XG2.C Low Temperature Steam-Formaldehyde Sterilizer FS-130，FS-M130，FS-K130，FS-M220，FS-L1303 refs	IIa MDR	EUDAMED record Report an error
Small load autoclaves with a chamber smaller than 1 standard sterilisation unit	Z12011305	Autoclave Dmax-N Autoclave MOST-T	IIa MDR	EUDAMED record Report an error
Autoclaves with a chamber larger than or equal to 1 standard sterilisation unit	Z12011304	Pulse Vacuum Sterilizer XG1.U,MAST-A,MAST-H,MAST-C,MAST-V,Clean VS3 refs	IIa MDR	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	Rapid Automatic Washer-Disinfector Rapid-A-520, Rapid-M-320 ,Victor6000,Smart-L,Smart-T3 refs	IIa MDR	EUDAMED record Report an error
Dental treatment units	Z12110101	Dental Unit GRACE-D2 refs	IIa MDR	EUDAMED record Report an error
Endoscope drying cabinets and storage	Z12011314	Flexible Endoscope Storage Cabinet ESC-GS-08,ESC-GD-08,ESC-PS-09,ESC-PD-09,ESS-PS-07,ESS-PD-07,ESA-PS-083 refs	I MDR	EUDAMED record Report an error
Endoscope sterilisers	Z12011313	Flexible Endoscope Washer-disinfector Rider60A,Rider60B,Rider50A,Rider50B,Rider40B,Rider30B3 refs	IIa MDR	EUDAMED record Report an error
Fixed scialytic lamps	Z12010701	Surgical Light SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35.3 refs	I MDR	EUDAMED record Report an error
High performance liquid chromatography systems	W0201050201	Glycohemoglobin Analyzer SGH-200、SGH-400、SGH-3103 refs	A IVDR	EUDAMED record Report an error
Operating tables	Z12011202	Operating Table STable-H7000, STable-H8500, STable H8500R, XHT-B, XHT-C ,XHT-D，XHT-D-U and XHT-F3 refs	I MDR	EUDAMED record Report an error
Plasma sterilisers	Z12011309	H2O2 Low Temperature Plasma Sterilizer PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100X3 refs	IIa MDR	EUDAMED record Report an error
Single energy linear accelerators	Z11010101	Medical Electron Linear Accelerator XHA600E、XHA14002 refs	IIb MDR	EUDAMED record Report an error
Ultrasonic cleaning equipment	Z12011302	Ultrasonic Washer CS-90-T,CS-90,CS-90-TA,CS-90-A,CS-80,CS-50,CS-30,CS-30-T,CS-10,CS-10-T3 refs	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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.