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ARTIFICIALIRIS with Fiber CUSTOMFLEX®

by HumanOptics Holding AG Germany EUDAMEDGUDID

Ref 00095001

Product code QBTEMDN P0399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number44911221836 Date10 Jun 2026IssuedStatusActive expires 12 Jun 2030
United StatesGUDID listing GUDID Number04049154000012 UDI-DIDate2 Oct 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 44911221836 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other
  • 44912221836 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
ARTIFICIALIRIS with Fiber CUSTOMFLEX® EUDAMED
Artificial Iris with Fiber GUDID
Generic Name
Implantable iris prosthesis
Model / Ref / Catalog
00095001, 95001
Primary DI / UDI-DI
04049154000012
Basic UDI-DI
04049154_AI_M1_H1_O1_X7
PMA Number
FDA Product Code
QBT
EMDN Code
P0399 Ocular prostheses - other
GMDN Term
Implantable iris prosthesis
Device Class
Class IIb EUDAMED
Class III GUDID
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Outer Diameter — 12.8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
00095001
GUDID
95001
Device ClassEUDAMED
Class IIb
GUDID
Class III

Manufacturer details

EUDAMED SRN
DE-MF-000017892

Other devices from HumanOptics Holding AG

See all devices from HumanOptics Holding AG →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No

Sources (2)

  • EUDAMED 5e685d18-7825-4c99-8fb0-243bf5021470 61 fields · synced 25 Oct 2026
  • FDA UDI d07b8d62-1613-484d-ac83-38c217e736c5 37 fields · synced 30 May 2026