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Antiseptic Applicator

EUDAMED

Class I (EU MDR)

Ref 70426Model Antiseptic Applicator

by Poly Medicure Limited

Identity

Trade Name
Antiseptic Applicator EUDAMED
Device Name
Antiseptic Applicator EUDAMED
Model / Reference
Antiseptic Applicator EUDAMED
70426 EUDAMED

Identifiers

Primary DI / UDI-DI
08902095704264 EUDAMED
Basic UDI-DI
890209544000ET EUDAMED
EMDN Code
Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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: Surgical utensil washer/disinfector

Antiseptic Applicator by Poly Medicure Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical utensil washer/disinfector.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
IN-MF-000043011
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED a7dca391-d0b5-486f-8c4a-607487df271a 61 fields · synced Jul 9, 2026