Kowa Ap-7000

FDA UDI

Class I (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name: KOWA AP-7000 FDA UDI
Generic Name: Perimeter, automatic FDA UDI
Device Name: KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results. Static quantitative perimetry examinations and kinetic perimetry examinations are available. FDA UDI
Model / Reference: FT10K FDA UDI
Description: KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results. Static quantitative perimetry examinations and kinetic perimetry examinations are available. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987646805113 FDA UDI
FDA Product Code: HPT FDA UDI
GMDN Term: Perimeter, automatic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1605 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 — 700 Millimeter FDA UDI
Depth — 430 Millimeter FDA UDI
Width — 730 Millimeter FDA UDI
Weight — 26 Kilogram FDA UDI

Category: Perimeter, automatic

Kowa Ap-7000 by Kowa Co. , Ltd. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Kowa Co. , Ltd.

Sources (1)

FDA UDI d00a06db-8137-490a-aaf8-c83984197800 35 fields · synced Jun 1, 2026