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Cortex Extractor [Charleux] 23g X 13mm (1/2"), curved

EUDAMED

Class IIa (EU MDR)

Ref 3007Model I/A Cannulas and Cortex Removal

by PSI/EYE-KO, Inc.

Identity

Trade Name
Cortex Extractor [Charleux] 23g X 13mm (1/2"), curved EUDAMED
Model / Reference
I/A Cannulas and Cortex Removal EUDAMED
3007 EUDAMED

Identifiers

Primary DI / UDI-DI
00840516104980 EUDAMED
Basic UDI-DI
0840516130004N EUDAMED
EMDN Code
Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Cortex Extractor [Charleux] 23g X 13mm (1/2"), curved by Psi/Eye-Ko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
PSI/EYE-KO, Inc.
EUDAMED SRN
US-MF-000022109
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 236f7656-ef48-413d-805c-109d82beb929 61 fields · synced Jul 25, 2026