SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

Address:No.7, MingPu Phase II, No.3279,Shanghai,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (4) Camera, Ophthalmic, General-Use (PJZ) (2) Tonometer, Manual (HKY) (2) Refractometer, Ophthalmic (HKO) (1) Topographer, Corneal, Ac-Powered (MMQ) (1)

Premarket Exempt

No Yes

Clear

Mediworks - 06945087505175 Catalog Number :

Device Class : 1

Duns Number: 527884077

Premarket Exempt : Yes

Product Code : MMQ

Prescription Use : No

Device Count : 1

MediWorks - 06945087510018 Catalog Number :

Device Description : The vision screening instrument is based on the principle of eccentric photo re The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases.

Device Class : 1

Duns Number: 527884077

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

MediWorks - 06945087516010 Catalog Number :

Device Description : The device is used to observe, capture and record retina images through examining pupil.

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

Mediworks - 06945087516102 Catalog Number :

Device Class : 2

Duns Number: 527884077

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : No

Device Count : 1

Mediworks - 06945087516201 Catalog Number :

Device Class : 2

Duns Number: 527884077

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : No

Device Count : 1

MediWorks - 06945087517017 Catalog Number :

Device Description : Tonometer is indicated for Intraocular Pressure (IOP) measurement .

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

MediWorks - 06945087517024 Catalog Number :

Device Description : Tonometer is indicated for Intraocular Pressure (IOP) measurement .

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

Mediworks - 06945087520000 Catalog Number :

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

Mediworks - 06945087525005 Catalog Number :

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

Mediworks - 06945087525012 Catalog Number :

Device Class : 2

Duns Number: 527884077

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

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