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Glocan Alpha Safety
EUDAMEDClass IIa (EU MDR)
Ref 4111162GModel 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 4111142GRef 4111242GRef 4111172GRef 4111182G
Identity
- Trade Name
- Glocan Alpha Safety 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) EUDAMED4111162G EUDAMED4111142G EUDAMED4111242G EUDAMED4111172G EUDAMED4111182G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545084998 EUDAMED08903545084981 EUDAMED08903545085049 EUDAMED08903545085001 EUDAMED08903545085018 EUDAMED
- Basic UDI-DI
- 8903545GMLIVC019KW EUDAMED
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH 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 Safety 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 1a57e1e5-edd5-4ffc-9620-3a4add682a9d 61 fields · synced Aug 1, 2026
- EUDAMED 365ce361-b3f5-45ba-bc6f-86d8c8432bdc 61 fields · synced May 16, 2026
- EUDAMED c50bddcd-cf11-4914-84ca-207449108bd2 61 fields · synced May 16, 2026
- EUDAMED a47b5cdd-9368-41a6-b53f-1b2b416daa34 61 fields · synced May 17, 2026
- EUDAMED 15d29652-648d-4ff6-aad4-157726be7146 61 fields · synced May 17, 2026