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[Pearce] Micro Iris Retractor, angled

EUDAMED

Class IIa (EU MDR)

Ref 8206Model Manual Handled Instruments

by PSI/EYE-KO, Inc.

Identity

Trade Name
[Pearce] Micro Iris Retractor, angled EUDAMED
Model / Reference
Manual Handled Instruments EUDAMED
8206 EUDAMED

Identifiers

Primary DI / UDI-DI
00840516107080 EUDAMED
Basic UDI-DI
08405161820063 EUDAMED
EMDN Code
Q021104 OPHTHALMIC SURGERY MANIPULATORS, 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

Category: Ophthalmic surgical probe, single-use

[Pearce] Micro Iris Retractor, angled by Psi/Eye-Ko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical probe, single-use.

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 2fa1a918-5834-492f-9c3f-eb35695b2d1e 61 fields · synced Jun 20, 2026