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Glofin
EUDAMEDClass IIa (EU MDR)
Ref 2011175GModel A.V. fistula needle set (Safety and without safety)Ref 2011155G
Identity
- Trade Name
- Glofin EUDAMED
- Device Name
- A.V fistula needle EUDAMED
- Model / Reference
- A.V. fistula needle set (Safety and without safety) EUDAMED2011175G EUDAMED2011155G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545002374 EUDAMED08903545002350 EUDAMED
- Basic UDI-DI
- 8903545GMLAVF006H2 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Glofin 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 | 8903545GMLAVF006H2 | 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 (2)
- EUDAMED 6ce63be6-0fcd-4ace-b9ef-f96fb4386b59 61 fields · synced Sep 17, 2026
- EUDAMED 30d06f47-3fc2-4e84-a4a1-4e9f7d926f8b 61 fields · synced May 18, 2026