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Gloflon Plus

EUDAMED

Class IIa (EU MDR)

Ref 4430162GModel I.V. Catheter with & without Injection valve and with & without wings (with & without safety); I.V. Catheter with an integrated 3 way stop cock (with & without safety); I.V catheter for infants; I.V. catheter for quick flash back (with & without safety)

by Global Medikit Limited

Identity

Trade Name
Gloflon Plus EUDAMED
Device Name
I.V. Catheter EUDAMED
Model / Reference
I.V. Catheter with & without Injection valve and with & without wings (with & without safety); I.V. Catheter with an integrated 3 way stop cock (with & without safety); I.V catheter for infants; I.V. catheter for quick flash back (with & without safety) EUDAMED
4430162G EUDAMED

Identifiers

Primary DI / UDI-DI
08903545078195 EUDAMED
Basic UDI-DI
8903545GMLIVC019KW EUDAMED
EMDN Code
C0101010101 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Gloflon Plus by Global Medikit Limited — 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
Global Medikit Limited
EUDAMED SRN
IN-MF-000013635
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 77176c84-4024-43fb-b26e-fe92d38b570a 61 fields · synced Jun 18, 2026