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Gloflex
EUDAMEDClass IIa (EU MDR)
Ref 4310012GModel Three way stop cock-Lipid resistant & non-lipid (blue, white, red tap); Intravenous Infusion system with multiple stop cock in line-3Way-Lipid resistant & non-lipid; Extension tubing with 3 way stop cock--Lipid resistant & non-lipidRef 4955032GRef 4955012GRef 4956022GRef 4320032GRef 4310022G
Identity
- Trade Name
- Gloflex EUDAMED
- Device Name
- Stopcocks EUDAMED
- Model / Reference
- Three way stop cock-Lipid resistant & non-lipid (blue, white, red tap); Intravenous Infusion system with multiple stop cock in line-3Way-Lipid resistant & non-lipid; Extension tubing with 3 way stop cock--Lipid resistant & non-lipid EUDAMED4310012G EUDAMED4955032G EUDAMED4955012G EUDAMED4956022G EUDAMED4320032G EUDAMED4310022G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545001018 EUDAMED08903545083120 EUDAMED08903545083106 EUDAMED08903545083144 EUDAMED08903545071004 EUDAMED08903545041014 EUDAMED
- Basic UDI-DI
- 8903545GMLSTC017P6 EUDAMED
- EMDN Code
- A0703 STOPCOCKS 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
Gloflex 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 | 8903545GMLSTC017P6 | 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 (6)
- EUDAMED 0387415d-443e-4803-8093-031dbf84c2ee 61 fields · synced Oct 6, 2026
- EUDAMED dd24a93d-a8b3-47d4-aa66-40203a918f43 61 fields · synced May 17, 2026
- EUDAMED 8344d8b3-4cc3-4e0e-b997-e64196dec4b2 61 fields · synced May 17, 2026
- EUDAMED 78e3182b-1e4e-4325-8076-d7291edc7882 61 fields · synced May 17, 2026
- EUDAMED 569c1e01-60f2-40bc-962f-1dd4fa472022 61 fields · synced May 18, 2026
- EUDAMED e4bd0ad1-9a01-4c88-87e5-e2a6bb308c53 61 fields · synced May 18, 2026