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Oncomale

EUDAMED

Class IIa (EU MDR)

Ref OM001

by Oncosem Onkolojik Sistemler San. ve Tic. A.Ş.

Identity

Trade Name
ONCOMALE EUDAMED
Device Name
ANTINEOPLASTIC CLOSED MALE CONNECTOR EUDAMED
Model / Reference
OM001 EUDAMED

Identifiers

Primary DI / UDI-DI
08680836100017 EUDAMED
Basic UDI-DI
B-08680836100017 EUDAMED
EMDN Code
A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Oncomale by Oncosem Onkolojik Sistemler San. ve Tic. A.Ş. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
TR-MF-000041122

Sources (1)

  • EUDAMED dc32760a-3a1f-4764-ac42-4a7bedd69005 61 fields · synced Jul 16, 2026