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Sterile Nelaton Catheter
EUDAMEDClass IIa (EU MDR)
Ref UR048000Model 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr
Identity
- Trade Name
- Sterile Nelaton Catheter EUDAMED
- Device Name
- Sterile Nelaton Catheter EUDAMED
- Model / Reference
- 6Fr、8Fr、10Fr、12Fr、14Fr、16Fr、18Fr、20Fr EUDAMEDUR048000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601003672 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSNC001MX EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Nelaton Catheter by Multigate Co., Ltd — 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 | 697201396MU2ASNNNSNC001MX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED 06f84462-67d0-46e4-a068-df9c572f1793 61 fields · synced Jun 19, 2026