Manufacturer

ChongQing SunKingdom Medical Instrument

ChinaLegal entities : ChongQing SunKingdom Medical Instrument Co., Ltd.

Markets : Denmark · France · Poland · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 3 · class I, II · latest in 2023 · see on the FDA website

EU representative : MedNet EC-REP GmbH (Germany)

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

Category	EMDN code	Registered models	Class	Contact
Tonometers	Z12120122	Applanation Tonometer SK-Q93/42 Applanation Tonometer SK-R93/42 Applanation Tonometer SK-T93/42 Non-contact Tonometer SK-5000A SK-5000A, SK-5000B2 refs	IIa MDR, 93/42	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - other	Z12120199	Fundus Camera SK-650B SK-660A, SK-650B, SK-680A, SK-680B, SK-680C3 refs Ocular Surface Analyzer DA-1 DA-1，DA-32 refs Wide-field Ophthalmic Imaging System SK-8000A SK-8000A,SK-8000B, SK-8000C3 refs	I MDR	EUDAMED record Report an error
Echophthalmographs	Z11040107	Ophthalmic Ultrasound Examination Instrument SK-2000AP93/42 Ophthalmic Ultrasound Examination Instrument SK-3000A93/42	IIa 93/42	EUDAMED record Report an error
Visual functional assessment equipment	Z1212012001	Perimeter SK-950B SK-950B,SK-950C2 refs Retinometer SK-6500A2 refs	I MDR	EUDAMED record Report an error
Computerised corneal topographs	Z12120123	Corneal topographer SK-7000A SK-7000A、SK-7000B2 refs	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	Ophthalmic Slit Lamp Microscope LS-1A LS-1A, LS-1B, LS-3, LS-4, LS-5, LS-5C, LS-6, LS-6C, LS-7, LS-7C, LS-7CS, LS-7CE, LS-7DS, LS-7DE, LS-8, LS-8A, LS-8C, LS-8D, LS-9, LS-9C, LS-9CS, LS-9D3 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.

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