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

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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