Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010531293

FEI Number

3010531293

Entity Name

HUMANOPTICS HOLDING AG

City/State/Country

Sankt Augustin North Rhine-Westphalia, DE

Establishment Address

Westerwaldstr. 11-13, Sankt Augustin North Rhine-Westphalia 53757, DE

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HumanOptics Holding AG (Owner Number: 10058390)

Owner / Operator Contact Address

Westerwaldstr. 11-13, Sankt Augustin, DE-NW 53757, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P170039

All Registered Proprietary Names

ARTIFICIALIRIS FiberFree SELECT Light Green ARTIFICIALIRIS FiberFree SELECT Light Brown ARTIFICIALIRIS FiberFree SELECT Medium Brown ARTIFICIALIRIS with Fiber STANDARD Black ARTIFICIALIRIS FiberFree SELECT Dark Green ARTIFICIALIRIS with Fiber CUSTOMFLEX® ARTIFICIALIRIS with Fiber SELECT Light Blue ARTIFICIALIRIS FiberFree CUSTOMFLEX® ARTIFICIALIRIS FiberFree SELECT Dark Brown ARTIFICIALIRIS with Fiber SELECT Dark Blue ARTIFICIALIRIS FiberFree STANDARD Black ARTIFICIALIRIS FiberFree SELECT Medium Blue CUSTOMFLEX ARTIFICIAL IRIS ARTIFICIALIRIS with Fiber SELECT Dark Green ARTIFICIALIRIS FiberFree SELECT Dark Blue ARTIFICIALIRIS with Fiber SELECT Medium Brown ARTIFICIALIRIS with Fiber SELECT Light Green ARTIFICIALIRIS FiberFree SELECT Light Blue ARTIFICIALIRIS with Fiber SELECT Dark Brown ARTIFICIALIRIS with Fiber SELECT Medium Blue ARTIFICIALIRIS with Fiber SELECT Light Brown ARTIFICIALIRIS FiberFree SELECT Medium Green ARTIFICIALIRIS with Fiber SELECT Medium Green

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBT	Artificial Iris	Unknown	Class 3	N/A	2018-09-10

Official Correspondent

Alexander Burka

US Agent Details

Barbara Fant Business: Clinical Research Consultants, Inc. Email: bsfant@crc-regulatory.com Phone: (513) 6073932

Related Public Records

Same Entity

HumanOptics Holding AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010531293. Last updated year: 2026. Please use registration number 3010531293 when referencing this establishment in official correspondence.