Identity
- Trade Name
- CompactCath Nelaton, Male, 14 Fr/Ch, 40cm EUDAMED
- Device Name
- Pre-lubricated urinary catheter EUDAMED
- Model / Reference
- 101603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892211830 EUDAMED
- Basic UDI-DI
- 385889221cathetersgelPA EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
CompactCath Nelaton, Male, 14 Fr/Ch, 40cm by Lentismed d.o.o. — Class I — 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 | 385889221cathetersgelPA | Class I | Active |
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Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (1)
- EUDAMED cc59a908-d425-413e-b593-a4b39c6727a2 61 fields · synced Jul 12, 2026