Identity
- Trade Name
- nelaton catheter EUDAMED
- Device Name
- Urethral Catheter EUDAMED
- Model / Reference
- I03106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879050523 EUDAMED
- Basic UDI-DI
- 471096971TCF28II010177 EUDAMED
- EMDN Code
- U01010502,U01010602,U010201 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
nelaton catheter by Pacific Hospital Supply 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 | 471096971TCF28II010177 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pacific Hospital Supply Co., Ltd.
- EUDAMED SRN
- TW-MF-000007247
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 6498e56d-ae2c-4959-a545-fbf5b66f4298 61 fields · synced Jul 20, 2026