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Medidial
EUDAMEDClass IIa (EU MDR)
Ref 4440016Model Intravenous Fluid Infusion Set with and without airvent, with 0.2 micron in-line filter, with graduated flow regulator, with auto air stop and priming filter, with standard and needleless y-site, with luer lock, with 3 way stop cock
Identity
- Trade Name
- Medidial EUDAMED
- Device Name
- Intravenous Fluid Infusion Set EUDAMED
- Model / Reference
- Intravenous Fluid Infusion Set with and without airvent, with 0.2 micron in-line filter, with graduated flow regulator, with auto air stop and priming filter, with standard and needleless y-site, with luer lock, with 3 way stop cock EUDAMED4440016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545081638 EUDAMED
- Basic UDI-DI
- 8903545GMLIVS007P7 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medidial 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 | 8903545GMLIVS007P7 | 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 22971433-f6a4-4d5a-ab99-bc0337b4fc0d 61 fields · synced Jul 14, 2026