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Gloflon Safety-1
EUDAMEDClass IIa (EU MDR)
Ref 41317BIModel 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)Ref 41316BIRef 41322BI
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) EUDAMED41317BI EUDAMED41316BI EUDAMED41322BI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545000608 EUDAMED08903545000592 EUDAMED08903545000639 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8903545GMLIVC019KW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Global Medikit Limited
- EUDAMED SRN
- IN-MF-000013635
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 6678fc40-b0b5-49f2-be33-708137974105 61 fields · synced Jul 20, 2026
- EUDAMED 3d400177-eaa1-41ac-88d9-06a92c56617d 61 fields · synced May 18, 2026
- EUDAMED cf0becae-61ab-4a80-8fb9-dfc34f9cea44 61 fields · synced May 19, 2026