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Gloveins Alpha
EUDAMEDClass IIa (EU MDR)
Ref 4291253GModel Extension set (Low & high pressure), coiled extension set with & without needle free connector, Extension line with &without needle free valve, Extension tube with clamp
Identity
- Trade Name
- Gloveins Alpha EUDAMED
- Device Name
- Extension Set EUDAMED
- Model / Reference
- Extension set (Low & high pressure), coiled extension set with & without needle free connector, Extension line with &without needle free valve, Extension tube with clamp EUDAMED4291253G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545004187 EUDAMED
- Basic UDI-DI
- 8903545GMLEXT020N8 EUDAMED
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Gloveins 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 | 8903545GMLEXT020N8 | 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 (1)
- EUDAMED e696fe8c-07de-48a1-a043-064ddb8ffa8a 61 fields · synced Jun 18, 2026