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Gloflon Safety-1

EUDAMED

Class IIa (EU MDR)

Ref 41324BIModel 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 Safety-1 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
41324BI EUDAMED

Identifiers

Primary DI / UDI-DI
08903545000646 EUDAMED
Basic UDI-DI
8903545GMLIVC019KW EUDAMED
EMDN Code
C0101010201 PERIPHERAL I.V. CATHETERS, WITH 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 Safety-1 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 5a2b5b65-c8ed-467a-a50f-6aa3c6aee5f2 61 fields · synced Jun 20, 2026