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Over The Needle (OTN) Catheter
EUDAMEDClass IIa (EU MDR)
Ref 13444Model Over The Needle (OTN) Catheter
Identity
- Trade Name
- Over The Needle (OTN) Catheter EUDAMED
- Device Name
- Over The Needle (OTN) Catheter EUDAMED
- Model / Reference
- Over The Needle (OTN) Catheter EUDAMED13444 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095134443 EUDAMED
- Basic UDI-DI
- 890209513440EK EUDAMED
- EMDN Code
- C010102 PERIPHERAL I.V. CATHETER SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Over The Needle (OTN) Catheter by Poly Medicure 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 | 890209513440EK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8ea24fe0-5fdc-4f57-82ea-c5dea3cbbeab 61 fields · synced Jul 17, 2026