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Glocan Alpha
EUDAMEDClass IIa (EU MDR)
Ref 4110182GModel 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 4110172GRef 4110242GRef 4110262G
Identity
- Trade Name
- Glocan Alpha 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) EUDAMED4110182G EUDAMED4110172G EUDAMED4110242G EUDAMED4110262G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545000189 EUDAMED08903545000172 EUDAMED08903545000219 EUDAMED08903545000226 EUDAMED
- Basic UDI-DI
- 8903545GMLIVC019KW EUDAMED
- EMDN Code
- C0101010102 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O 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
Glocan Alpha 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 (4)
- EUDAMED ddfd363c-1714-4f2b-b676-1bf826d2f1a2 61 fields · synced Jul 23, 2026
- EUDAMED 5a873ff0-e03d-4fda-8c2b-939249128587 61 fields · synced May 16, 2026
- EUDAMED 83e47a45-ecce-4cb7-b3fc-97d95dd49e94 61 fields · synced May 17, 2026
- EUDAMED 0978ab3e-22bd-4a96-ace2-1f566e844900 61 fields · synced May 18, 2026