Identity
- Trade Name
- KONTICUR® Kath H+F EUDAMED
- Device Name
- Nelaton Catheter EUDAMEDHydrophilic Nelaton Catheter EUDAMEDHydrophilic Nelaton Catheter EUDAMED
- Model / Reference
- WHF10 EUDAMEDWHF16 EUDAMEDWHF12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970675359748 EUDAMED06970675359779 EUDAMED06970675359755 EUDAMED
- Basic UDI-DI
- 697067535IMP2ASNNNSNCH1YG EUDAMEDB-06970675359779 EUDAMEDB-06970675359748 EUDAMEDB-06970675359755 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
KONTICUR® Kath H+F by Integral Medical Products Co., Ltd. — Class IIa — MDD, 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
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
- GoldCath — DEMERSAN BIYOTEKNOLOJI İMALAT SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697067535IMP2ASNNNSNCH1YG | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697067535IMP2ASNNNSNCH1YG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Integral Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED 3afed424-e465-4580-a33a-ddecb9c7c882 61 fields · synced Jul 24, 2026
- EUDAMED fc321f7b-1288-4682-a4e5-da2c217c46a4 61 fields · synced Jun 11, 2026
- EUDAMED 91cf814f-f23b-404a-a536-b2dfbb27a40e 61 fields · synced Jun 18, 2026
- EUDAMED 448fa971-9c52-4816-ade9-26f18b5512bb 61 fields · synced Jun 20, 2026
- EUDAMED 418900bd-c15e-4b72-8e92-4ed0ba2c95d1 61 fields · synced Jul 13, 2026
- EUDAMED a82146de-a635-4380-94ad-a7bec4041ac7 61 fields · synced Jul 17, 2026
- EUDAMED 1b8bed0a-0139-4be9-bd37-4ab94c1ac96a 61 fields · synced Jul 24, 2026