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MonacoPro

by Optos plc United Kingdom EUDAMED510(k)GUDID

Ref A10700Model P200TE

Product code MYCEMDN Z12120114

Overview

The MonacoPro is an ultra-widefield scanning laser ophthalmoscope and spectral domain retinal imaging solution. It is designed to provide diagnostic imaging of the retina for eyecare professionals.

This device is a Class IIa medical device that is not sterile and is intended for non-implantable, single-use applications. It is authorized under FDA 510k and MDR regulations and is identified by reference code A10700 and model P200TE.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK233602 Date9 May 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number50570561070088 Basic UDI-DIDate15 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05057056107004 UDI-DIDate2 Apr 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Trade Name
MonacoPro EUDAMED
OCT Ophthalmoscope GUDID
Generic Name
Scanning-laser ophthalmoscope/retinal optical coherence tomography system
Device Name
Monaco
Model / Ref / Catalog
P200TE, A10700
Primary DI / UDI-DI
05057056107004
Basic UDI-DI
50570561070088
Direct Marketing DI
05057056107004
FDA Product Code
MYC, OBO
EMDN Code
Z12120114 Ophthalmoscopes
GMDN Term
Scanning-laser ophthalmoscope/retinal optical coherence tomography system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.1570
Market of Registration
Northern Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000019460
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Questions

  • What is the primary function of the MonacoPro?

    The MonacoPro is an ultra-widefield scanning laser ophthalmoscope and spectral domain retinal imaging solution. It is designed to assist eyecare professionals by providing diagnostic imaging of the retina.

  • Is the MonacoPro intended for single-use or reuse?

    The MonacoPro is intended for single-use applications. It is not designed for reuse, which helps maintain the integrity and performance standards required for diagnostic retinal imaging.

  • Does the device require sterilization?

    No, the MonacoPro is supplied as a non-sterile device. As it is a non-implantable diagnostic imaging solution, it does not require a sterile state for its intended use in an eyecare clinical setting.

  • What are the regulatory authorizations for this device?

    The MonacoPro is authorized under both FDA 510k and MDR regulations. It is classified as a Class IIa medical device, ensuring it meets the necessary regulatory requirements for its specific diagnostic function.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED fcd44d49-d03b-4dc4-99e3-5863558df593 61 fields · synced 23 Oct 2026
  • FDA UDI 1ae8c9de-f4c7-444b-9ba6-61365832f161 35 fields · synced 30 May 2026
  • FDA 510(k) K173707 1 fields · synced 18 May 2026