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Gloflon Safety-2
EUDAMEDClass IIa (EU MDR)
Ref 41420BBModel 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 41417BBRef 41426BBRef 41416BBRef 4580172GRef 40214BBCRef 40218BBCRef 4580162GRef 40220BBCRef 4580202GRef 4580182GRef 4580142GRef 4580222GRef 41422BBRef 41424BBRef 40222BBCRef 40216BBC
Identity
- Trade Name
- Gloflon Safety-2 EUDAMEDGloflon Safety EUDAMEDGloflon 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) EUDAMED41420BB EUDAMED41417BB EUDAMED41426BB EUDAMED41416BB EUDAMED4580172G EUDAMED40214BBC EUDAMED40218BBC EUDAMED4580162G EUDAMED40220BBC EUDAMED4580202G EUDAMED4580182G EUDAMED4580142G EUDAMED4580222G EUDAMED41422BB EUDAMED41424BB EUDAMED40222BBC EUDAMED40216BBC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545000691 EUDAMED08903545000677 EUDAMED08903545021719 EUDAMED08903545000660 EUDAMED08903545071882 EUDAMED08903545000011 EUDAMED08903545000042 EUDAMED08903545071875 EUDAMED08903545000059 EUDAMED08903545071905 EUDAMED08903545071899 EUDAMED08903545071868 EUDAMED08903545071912 EUDAMED08903545000707 EUDAMED08903545000714 EUDAMED08903545000066 EUDAMED08903545000028 EUDAMED
- Basic UDI-DI
- 8903545GMLIVC019KW EUDAMED
- EMDN Code
- C0101010201 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMEDC0101010101 PERIPHERAL I.V. CATHETERS, W/O 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
Gloflon Safety-2 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 (17)
- EUDAMED a8e160a7-c926-4f72-a973-d62d849b84c4 61 fields · synced Aug 4, 2026
- EUDAMED 1717b490-6a83-40db-8d2e-f97063406975 61 fields · synced May 17, 2026
- EUDAMED afaa9b0d-77c5-4a60-aa3b-170d5d87f221 61 fields · synced May 17, 2026
- EUDAMED 4dd26243-6a36-4989-8028-e07a56c46c25 61 fields · synced May 17, 2026
- EUDAMED 2a8011ad-34af-416f-a7c6-135e6b5248cc 61 fields · synced May 17, 2026
- EUDAMED b5786f11-c5c7-4712-80b4-174d184ad682 61 fields · synced May 17, 2026
- EUDAMED 391c2c96-52f8-43a3-bf3c-c94a04322128 61 fields · synced May 17, 2026
- EUDAMED 2af82448-2d6b-4a60-b6bb-b7cc17d5596e 61 fields · synced May 17, 2026
- EUDAMED 137531c7-6c1b-4aca-8a52-91e84bf120bc 61 fields · synced May 18, 2026
- EUDAMED 0e3063d8-f33d-43ac-a66a-9d2700d23f8c 61 fields · synced May 18, 2026
- EUDAMED 2535e7db-ef88-4b4d-975f-9d12653a7f50 61 fields · synced May 18, 2026
- EUDAMED c67448a6-796f-4a21-bcd3-6866f6132cf4 61 fields · synced May 18, 2026
- EUDAMED fae2bfe8-355b-4308-af7f-b2e9acebe1c8 61 fields · synced May 18, 2026
- EUDAMED e4148bb3-d601-4a98-9a7a-1cb0d1757940 61 fields · synced May 18, 2026
- EUDAMED ada03cc9-68df-47b9-864d-e576900d5760 61 fields · synced May 18, 2026
- EUDAMED 4473322b-cd0b-4cc2-adba-bd7989801ecf 61 fields · synced May 18, 2026
- EUDAMED 71c8c08e-72c4-4fc7-bf61-91b9d24c75df 61 fields · synced May 19, 2026