← Back to catalogue
Glofin Safety
EUDAMEDClass IIa (EU MDR)
Ref 2012165GModel A.V. fistula needle set (Safety and without safety)Ref 2012155G
Identity
- Trade Name
- Glofin Safety EUDAMED
- Device Name
- A.V fistula needle EUDAMED
- Model / Reference
- A.V. fistula needle set (Safety and without safety) EUDAMED2012165G EUDAMED2012155G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545081591 EUDAMED08903545081584 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 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 | 8903545GMLAVF006H2 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Global Medikit Limited
- EUDAMED SRN
- IN-MF-000013635
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 69bb3f29-0b62-44e0-b368-118751a3fa28 61 fields · synced Jul 12, 2026
- EUDAMED 6a157dbc-73f7-469d-a456-767d883a2a86 61 fields · synced May 19, 2026