Identity
- Trade Name
- MICROPERIMETER FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. With reference to the Microperimeter MP-3, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added. FDA UDI
- Model / Reference
- MP-3 type S FDA UDI
- Description
- The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. With reference to the Microperimeter MP-3, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101544 FDA UDI
- FDA Product Code
- HKI FDA UDIHPT FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI886.1605 FDA UDI
- Commercial Distribution
- 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
Category: Ophthalmic fundus cameraPerimeter, automatic
Microperimeter by Nidek, Inc. — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI 9887bde8-bf49-4148-834e-48552ea8f132 34 fields · synced Jun 8, 2026