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Mediflon Safety Two
EUDAMEDClass IIa (EU MDR)
Ref 4590262Model I.V. Catheter with & without Injection valve and with & without wings (with & without safety); I.V. Catheter with an integrated 3 way stop cock (with & without safety); I.V catheter for infants; I.V. catheter for quick flash back (with & without safety)Ref 4590242Ref 4590182Ref 4590202Ref 4590162Ref 4590172Ref 4590142
Identity
- Trade Name
- Mediflon Safety Two EUDAMED
- Device Name
- I.V. Catheter EUDAMED
- Model / Reference
- I.V. Catheter with & without Injection valve and with & without wings (with & without safety); I.V. Catheter with an integrated 3 way stop cock (with & without safety); I.V catheter for infants; I.V. catheter for quick flash back (with & without safety) EUDAMED4590262 EUDAMED4590242 EUDAMED4590182 EUDAMED4590202 EUDAMED4590162 EUDAMED4590172 EUDAMED4590142 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545084899 EUDAMED08903545015893 EUDAMED08903545015862 EUDAMED08903545015879 EUDAMED08903545015848 EUDAMED08903545015855 EUDAMED08903545015831 EUDAMED
- Basic UDI-DI
- 8903545GMLIVC019KW EUDAMED
- EMDN Code
- C0101010201 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Mediflon Safety Two 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 | 8903545GMLIVC019KW | 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 (7)
- EUDAMED c079613d-b29f-4f2f-b664-38d7e28b1e21 61 fields · synced Aug 4, 2026
- EUDAMED d9b7e05a-7b0e-458a-ae75-4c4c5ecadc7d 61 fields · synced May 16, 2026
- EUDAMED 3bf5be00-ddf5-43af-acc4-ba3a0977b34f 61 fields · synced May 17, 2026
- EUDAMED c3f6f1ae-f93f-49d3-947f-60c28743d9f8 61 fields · synced May 18, 2026
- EUDAMED 73dded2c-438e-44e0-8129-db810fe40858 61 fields · synced May 18, 2026
- EUDAMED 72b0260d-4516-46f4-952b-e9e65148e2f1 61 fields · synced May 19, 2026
- EUDAMED a9fc025a-3581-4eb1-b2b0-e074b609eeb9 61 fields · synced May 19, 2026