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LentisCath Nelaton, Pediatric, 8 Fr/Ch, 30cm
EUDAMEDClass I (EU MDR)
Ref 101416Ref 101516
Identity
- Trade Name
- LentisCath Nelaton, Pediatric, 8 Fr/Ch, 30cm EUDAMEDLentisCath+ Nelaton, Pediatric, 8 Fr/Ch, 30cm EUDAMED
- Device Name
- Intermittent Urinary Catheter EUDAMED
- Model / Reference
- 101416 EUDAMED101516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892210857 EUDAMED03858892211458 EUDAMED
- Basic UDI-DI
- 385889221cathetershydroJE 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
Category: Intermittent urethral drainage catheter, non-antimicrobial, single-use
LentisCath Nelaton, Pediatric, 8 Fr/Ch, 30cm by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- GoldCath — DEMERSAN BIYOTEKNOLOJI İMALAT SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
- Disposable Intermittent Catheter — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class I
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 | 385889221cathetershydroJE | Class I | Active |
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Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (2)
- EUDAMED 75132c5d-5c4d-4db9-8762-23d9bff4161d 61 fields · synced Jul 30, 2026
- EUDAMED 4b07b499-28bc-4073-9051-d430b82687e7 61 fields · synced May 18, 2026