Mp-1s

FDA UDI

Class II (US FDA UDI)

by Nidek Technologies Srl

Identity

Trade Name: MP-1S FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: The MP-1S MICRO PERIMETER is indicated for use as: ·Color retinography ·Fixation examiner ·Fundus-related microperimetry ·Visual rehabilitation FDA UDI
Model / Reference: MP-1S FDA UDI
Description: The MP-1S MICRO PERIMETER is indicated for use as: ·Color retinography ·Fixation examiner ·Fundus-related microperimetry ·Visual rehabilitation FDA UDI

Identifiers

Primary DI / UDI-DI: B310MP1S0 FDA UDI
FDA Product Code: HKI FDA UDI
HPT FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 FDA UDI
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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic fundus camera Perimeter, automatic

Mp-1s by Nidek Technologies Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Nidek Technologies Srl

Sources (1)

FDA UDI 801daecb-8371-4fe3-827f-cbeb7f512e1e 33 fields · synced Jun 8, 2026