MEDIZS Inc.

Address:94-10, Techno 2-ro, Yuseong-gu,Daejeon,KR

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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

Chart, Visual Acuity (HOX) (1) Projector, Ophthalmic (HOS) (1) Refractometer, Ophthalmic (HKO) (1) Refractor, Manual, Non-Powered, Including Phoropter (HKN) (1)

Premarket Exempt

Yes

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Medizs Digitalized Refractor DR-19 - 08809358430284 Catalog Number : DR-19

Device Description : Medizs Digitalized Refractor DR-19 is an automated digital phoropter.Operator ca Medizs Digitalized Refractor DR-19 is an automated digital phoropter.Operator can use it to find right eye glasses for patient's vision correction.

Device Class : 1

Duns Number: 557804864

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : No

Device Count : 1

Medizs Auto Refractometer-Keratometer - 08809358430291 Catalog Number : RK-11

Device Description : Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Bo Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry.And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction.

Device Class : 1

Duns Number: 557804864

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

Medizs LED VIsual Acuity Chart LC-13 - 08809358430307 Catalog Number : LC-13

Device Description : Medizs LED Visual Acuity Chart LC-13 is various chart for helping patient to mak Medizs LED Visual Acuity Chart LC-13 is various chart for helping patient to make a vision test.It has Snellen, Landolt, etc.

Device Class : 1

Duns Number: 557804864

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : No

Device Count : 1

Medizs Auto Chart Projector CP-11 - 08809358430314 Catalog Number : CP-11

Device Description : Medizs Auto Chart Projector CP-11 is an atomated chart projection device for pat Medizs Auto Chart Projector CP-11 is an atomated chart projection device for patient's vision test.

Device Class : 1

Duns Number: 557804864

Premarket Exempt : Yes

Product Code : HOS

Prescription Use : No

Device Count : 1

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