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Capsule Polisher 23g, side port

EUDAMED

Class IIa (EU MDR)

Ref 6001Model Capsule Polishers

by PSI/EYE-KO, Inc.

Identity

Trade Name
Capsule Polisher 23g, side port EUDAMED
Model / Reference
Capsule Polishers EUDAMED
6001 EUDAMED

Identifiers

Primary DI / UDI-DI
00840516105550 EUDAMED
Basic UDI-DI
0840516160005B 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

Capsule Polisher 23g, side port 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 1c447cca-191a-42d9-8881-2509643acd36 61 fields · synced Jun 12, 2026