imovifa

FDA UDI

Class I (US FDA UDI)

by Crewt Medical Systems, Inc.

Identity

Trade Name: imovifa FDA UDI
Generic Name: Perimeter, automatic FDA UDI
Device Name: An imovifa is used to perform visual field testing by recording the patient's reaction to small light spots automatically displayed at various positions. FDA UDI
Model / Reference: imovifa FDA UDI
Description: An imovifa is used to perform visual field testing by recording the patient's reaction to small light spots automatically displayed at various positions. FDA UDI

Identifiers

Primary DI / UDI-DI: 04573277310111 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

Yes

FDA UDI

Category: Perimeter, automatic

imovifa by Crewt Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perimeter, automatic.

VisuALL VRP S — Olleyes, Inc. · Class I
Medmont Automated Perimeter M700 USB — MEDMONT INTERNATIONAL PTY LTD · Class I
PalmScan VF2000 — MICRO MEDICAL DEVICES, INC. · Class I
COMPASS — CENTERVUE S.P.A. · Class IIa
Virtual Eye Software — VIRTUAL VISION HEALTH · Class I
Virtual Field — Field Virtual Inc · Class I
VisionOne — PeriVision SA · Class I
Twinfield 3 — OCULUS Optikgeräte GmbH · Class I

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: Crewt Medical Systems, Inc.

Sources (1)

FDA UDI afee792e-ab9a-48eb-a26c-c6569adeaa9e 34 fields · synced May 31, 2026