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Glothin
EUDAMEDClass IIa (EU MDR)
Ref 4100182GModel 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 4100202GRef 4100222GRef 4100162GRef 4100242G
Identity
- Trade Name
- Glothin 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) EUDAMED4100182G EUDAMED4100202G EUDAMED4100222G EUDAMED4100162G EUDAMED4100242G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545000301 EUDAMED08903545000318 EUDAMED08903545000325 EUDAMED08903545000288 EUDAMED08903545000332 EUDAMED
- Basic UDI-DI
- 8903545GMLIVC019KW EUDAMED
- EMDN Code
- C0101010101 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
Glothin 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 (5)
- EUDAMED 4c1c8629-3d48-42ed-b85c-70c129f4d025 61 fields · synced Jul 22, 2026
- EUDAMED d716ea20-9a63-4626-a6be-51e7ae35c1fe 61 fields · synced May 11, 2026
- EUDAMED d7cb9244-8d3c-4123-93a0-df7e4a81868c 61 fields · synced May 16, 2026
- EUDAMED bd2278a7-f820-4176-acaa-4bdf659b8fe2 61 fields · synced May 17, 2026
- EUDAMED b2699e69-0e44-47e8-b585-8742b0e3974a 61 fields · synced May 18, 2026