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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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IOLs, aphakic / Family Aspira-aA/Y — 4 UDI-DI variants, MDR

MD Atlas
HumanOptics Holding AG

Data from EUDAMED, last updated May 23, 2026

IOLs, aphakic / Family Aspira-aA/Y

04049154_PC_M2_H2_O2_BU

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: HumanOptics Holding AG

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Device characteristics

Implantable

Legacy certificates

Certificate number: 44912221836
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: TÜV NORD CERT GmbH (0044)
Validity: Jun 13, 2025 → Jun 12, 2030

Identity & classification

Basic UDI-DI: 04049154_PC_M2_H2_O2_BU
Device name: IOLs, aphakic / Family Aspira-aA/Y
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Jul 4, 2025

Manufacturer & authorised representative

Manufacturer

Name: HumanOptics Holding AG
SRN: DE-MF-000017892
Country: Germany
Email: prrc@humanoptics.com
Phone: +49 (0) 9131 50665-0

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01JZAXHRZWE3BBJZBM7GNX8XG5

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

0008440004049154000074
0008640004049154500338
0008640004049154499304
0008645004049154499717