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Gloval
EUDAMEDClass IIa (EU MDR)
Ref 4142202GModel 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 4142162GRef 4142242GRef 4142262GRef 4142172GRef 4142142G
Identity
- Trade Name
- Gloval 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) EUDAMED4142202G EUDAMED4142162G EUDAMED4142242G EUDAMED4142262G EUDAMED4142172G EUDAMED4142142G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545000387 EUDAMED08903545000356 EUDAMED08903545000400 EUDAMED08903545020903 EUDAMED08903545000363 EUDAMED08903545000349 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
Gloval 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 (6)
- EUDAMED c1c29c6a-9bae-48a6-b8b7-05820ac8472f 61 fields · synced Aug 1, 2026
- EUDAMED 95ba9ad7-eee4-4c8b-ac11-5db02da918e0 61 fields · synced May 17, 2026
- EUDAMED 30404650-4e31-4a7c-b56f-9df03704a163 61 fields · synced May 18, 2026
- EUDAMED e20f341d-18d6-46b7-8097-483f9ab1eb3b 61 fields · synced May 18, 2026
- EUDAMED d58fa499-a13d-47e7-bb10-091f51502d65 61 fields · synced May 18, 2026
- EUDAMED dd5be737-da9e-4e5f-a8da-07493c93b702 61 fields · synced May 18, 2026