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Vein-O-Line

EUDAMED

Class IIa (EU MDR)

Ref GS-3034

by Romsons International (Unit II)

Identity

Trade Name
VEIN-O-LINE EUDAMED
Device Name
Extension Line EUDAMED
Model / Reference
GS-3034 EUDAMED

Identifiers

Primary DI / UDI-DI
08902120303424 EUDAMED
Basic UDI-DI
8902120C011RR EUDAMED
EMDN Code
A03020101 LOW PRESSURE EXTENSION LINES 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

Vein-O-Line by Romsons International (Unit II) — 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

EUDAMED SRN
IN-MF-000024594
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED a998c901-fff1-42f0-86d1-c215393591f5 61 fields · synced Jun 18, 2026