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Kethin
EUDAMEDClass IIa (EU MDR)
Ref 4100222Model 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 4100182Ref 4100162Ref 4100172Ref 4100202Ref 4100262Ref 4100242
Identity
- Trade Name
- Kethin 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) EUDAMED4100222 EUDAMED4100182 EUDAMED4100162 EUDAMED4100172 EUDAMED4100202 EUDAMED4100262 EUDAMED4100242 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545015329 EUDAMED08903545015305 EUDAMED08903545015282 EUDAMED08903545015299 EUDAMED08903545015312 EUDAMED08903545020842 EUDAMED08903545015336 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
Kethin 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 a7afb291-01d1-4f11-bc14-1ca6cdeea7bd 61 fields · synced Jul 14, 2026
- EUDAMED 1a5af69e-0b64-4caa-83b7-67eff9cff220 61 fields · synced May 17, 2026
- EUDAMED 58b59b6c-461e-4cc2-898d-c10beb8d2377 61 fields · synced May 17, 2026
- EUDAMED 5452004f-04be-43a2-8c69-f2923b3b0515 61 fields · synced May 18, 2026
- EUDAMED 782255d8-7fad-4de0-b91f-5ed6fa4ed132 61 fields · synced May 18, 2026
- EUDAMED 9a23fcce-0c9b-4c25-aa55-3cd2da60115b 61 fields · synced May 18, 2026
- EUDAMED 00304295-f541-4e6b-b3a5-9e327273c1ee 61 fields · synced May 18, 2026