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Gloveins
EUDAMEDClass IIa (EU MDR)
Ref 4260103GModel 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 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 EUDAMED4260103G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545003968 EUDAMED
- Basic UDI-DI
- 8903545GMLEXT020N8 EUDAMED
- EMDN Code
- A03020101 LOW 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 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 d08d0ddb-00e6-45cc-89ff-5766950de92c 61 fields · synced Jun 19, 2026