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Double Lumen Drainage Accessory

EUDAMED

Class IIa (EU MDR)

Ref 10535Model 10800

by Redax S.p.A.

Identity

Trade Name
Double Lumen Drainage Accessory EUDAMED
Device Name
UNICO - PERCUTANEOUS KIT CH 9 EUDAMED
Model / Reference
10800 EUDAMED
10535 EUDAMED

Identifiers

Primary DI / UDI-DI
08034139291178 EUDAMED
Basic UDI-DI
803413929UNICO1aRF EUDAMED
EMDN Code
A070101 SUCTION TUBING ADAPTERS AND CONNECTORS EUDAMED

Classification

Device Class
Class IIa 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

Double Lumen Drainage Accessory by Redax S.p.A. — 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
Redax S.p.A.
EUDAMED SRN
IT-MF-000019320

Sources (1)

  • EUDAMED ff8a3ffc-7afa-4bff-9f09-16d7480dfc7d 61 fields · synced Jul 23, 2026