eyemate®-Reader

by Implandata Ophthalmic Products GmbH

Ref REA320100

Active European Union

CE MDR

Valid until

1 Nov 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number2246552CE01	Date1 Jun 2026Issued	StatusActive expires 1 Nov 2030
European Union	CE/MDR	Number2246552TD01	Date1 Jun 2026Issued	StatusActive expires 1 Jun 2031
European Union	CE/MDR	Number426064817REA326L Basic UDI-DI 04260648170305UDI-DI	Date6 Dec 2021Registered	StatusActive

Certificates

2 certificates · EUDAMED

2246552TD01 Active Reissued

Technical documentation EU MDR

Certifier

DEKRA Certification B.V. 0344

Issued
1 Jun 2026

Expires
1 Jun 2031
2246552CE01 Restricted

Quality management system EU MDR

Certifier

DEKRA Certification B.V. 0344

Issued
1 Jun 2026

Expires
1 Nov 2030

Reason
Not on market

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: eyemate®-Reader System
Model / Reference: REA320100

Primary DI / UDI-DI: 04260648170305
Basic UDI-DI: 426064817REA326L
Direct Marketing DI: 04260648170305
EMDN Code: J0780 Ophthalmological use active implantable devices - accessories

Device Class: Class III
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: DE-MF-000005431

Other devices from Implandata Ophthalmic Products GmbH

eyemate®-SC

Class III
Silicone Paddings

Class III

Properties

Measuring Function

Other properties (12)

Sterile: 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