Acunex®

by Teleon Surgical B.V. 2 variants

Ref 426021

Active European Union

CE MDR

Valid until

1 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number8719378002DS Basic UDI-DI 08719378260214UDI-DI	Date17 Aug 2026Registered	StatusActive
European Union	CE/MDR	Number2259166CE01	Date24 Apr 2026Issued	StatusActive expires 1 Feb 2030
European Union	CE/MDR	Number2259166TD01	Date24 Apr 2026Issued	StatusActive expires 1 Feb 2030

Certificates

2 certificates · EUDAMED

2259166CE01 Active Supplemented

Quality management system EU MDR

Certifier

DEKRA Certification B.V. 0344

Issued
24 Apr 2026

Expires
1 Feb 2030

Reason
Change approved
2259166TD01 Active Supplemented

Technical documentation EU MDR

Certifier

DEKRA Certification B.V. 0344

Issued
24 Apr 2026

Expires
1 Feb 2030

Reason
Change approved

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Hydrophobic Acrylic Intraocular Lens
Model / Reference: 426021

Primary DI / UDI-DI: 08719378260214
Basic UDI-DI: 8719378002DS
EMDN Code: P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC

Device Class: Class IIb
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: NL-MF-000003406

Other devices from Teleon Surgical B.V.

Lentis®

Class IIb
Acunex®

Class IIb

Properties

Sterile
Implantable

Other properties (12)

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