KOWA nonmyd a-DIII

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA nonmyd a-DIII FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface. FDA UDI
Model / Reference: K9L58K FDA UDI
Description: KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646800606 FDA UDI
510(k) Number: K082767 FDA UDI
FDA Product Code: HKI FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Dimensions & Sizes

Size: Height — 462 Millimeter FDA UDI
Depth — 505 Millimeter FDA UDI
Width — 310 Millimeter FDA UDI
Weight — 22 Kilogram FDA UDI

Category: Ophthalmic fundus camera

KOWA nonmyd a-DIII by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RetCam 3 — Natus Medical, Inc. · Class II
Volk Pictor VP1ANT — VOLK OPTICAL INC. · Class II
VISUCAM 224 — Carl Zeiss Meditec AG · Class II
NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kowa Co. , Ltd.

Sources (1)

FDA UDI 903a6991-7b9e-41ed-a21d-4edd2505845b 36 fields · synced May 31, 2026