KOWA nonmyd WX

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA nonmyd WX FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface. FDA UDI
Model / Reference: K9L57FK FDA UDI
Description: KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646806592 FDA UDI
510(k) Number: K101628 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 548 Millimeter FDA UDI
Depth — 504 Millimeter FDA UDI
Width — 310 Millimeter FDA UDI
Weight — 21 Kilogram FDA UDI

Category: Ophthalmic fundus camera

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

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Also classified as Ophthalmic fundus camera.

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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 fd583fb5-791b-44b6-9903-e1165e2c7a61 36 fields · synced May 30, 2026