Kowa Vx-10

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA VX-10 FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic. FDA UDI
Model / Reference: K9L48K FDA UDI
Description: KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646802006 FDA UDI
510(k) Number: K043213 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 — 620 Millimeter FDA UDI
Depth — 520 Millimeter FDA UDI
Width — 400 Millimeter FDA UDI
Weight — 39 Kilogram FDA UDI

Category: Ophthalmic fundus camera

Kowa Vx-10 by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 4d1a3f30-e96c-4efd-a2be-c847d9086bee 36 fields · synced Jun 8, 2026