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Kowa Dr-1α

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name
KOWA DR-1α FDA UDI
Generic Name
Ophthalmic fundus camera FDA UDI
Device Name
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. FDA UDI
Model / Reference
DE2K FDA UDI
Description
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. FDA UDI

Identifiers

Primary DI / UDI-DI
04987646807728 FDA UDI
510(k) Number
K190573 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Kowa Dr-1α by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kowa Co. , Ltd.

Sources (1)

  • FDA UDI 5cbf99cc-65a9-4e57-a9e9-448e178db7ad 36 fields · synced Jun 8, 2026