KONAN MEDICAL, INC.

Address:10-29 MIYANISHI-CHO,NISHINOMIYA Hyogo,JP

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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

Microscope, specular (NQE) (4) System, image management, ophthalmic (NFJ) (2) Camera, ophthalmic, ac-powered (HKI) (1) MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC (HRM) (1)

Premarket Exempt

No Yes

Clear

NA - 04582275250107 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : HKI

Prescription Use : No

Device Count : 1

NA - 04582275250374 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NQE

Prescription Use : No

Device Count : 1

NA - 04582275250404 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NQE

Prescription Use : No

Device Count : 1

NA - 04582275250428 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

N/A - 04582275250619 Catalog Number :

Device Class : 1

Duns Number: 690768619

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : No

Device Count : 1

NA - 04582275250626 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NQE

Prescription Use : No

Device Count : 1

NA - 04582275250657 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

NA - 04582275250664 Catalog Number :

Device Class : 2

Duns Number: 690768619

Premarket Exempt : No

Product Code : NQE

Prescription Use : No

Device Count : 1

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