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Gloflon Plus
EUDAMEDClass IIa (EU MDR)
Ref 4430262GModel 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 4430202GRef 4430142GRef 4430182GRef 4430242G
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) EUDAMED4430262G EUDAMED4430202G EUDAMED4430142G EUDAMED4430182G EUDAMED4430242G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545078256 EUDAMED08903545078225 EUDAMED08903545078188 EUDAMED08903545078218 EUDAMED08903545078249 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
| 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 (5)
- EUDAMED ebe99ae9-3ae7-4e29-8335-2bcce2df5e75 61 fields · synced Jul 31, 2026
- EUDAMED 30103cb3-086f-41f1-8110-6aa88f615dc2 61 fields · synced May 18, 2026
- EUDAMED 0e16a287-ef1e-4bf5-b745-884c190e1b4c 61 fields · synced May 18, 2026
- EUDAMED 967b1f37-e113-4479-9a14-8fe4b10dbb35 61 fields · synced May 18, 2026
- EUDAMED 6d515852-08af-4154-b97e-0f9b7e5c54f5 61 fields · synced May 19, 2026