KOWA nonmyd 8s

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA nonmyd 8s FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic. FDA UDI
Model / Reference: K9L63K FDA UDI
Description: The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646807612 FDA UDI
FDA Product Code: PJZ 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

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 8s by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic fundus camera.

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Welch Allyn — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
iCam — OPTOVUE, INC. · Class II
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 d50a24a8-c1e1-4eb2-9b69-5d825d774654 35 fields · synced Jun 8, 2026