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UROMED SIMPLYCATH mobil
EUDAMEDClass I (EU MDR)
Ref 3612.08Ref 3602.14Ref 3613.14Ref 3603.10Ref 3613.10Ref 3612.16Ref 3602.10Ref 3613.16Ref 3602.08Ref 3613.12Ref 3603.12Ref 3602.12
Identity
- Trade Name
- UROMED SIMPLYCATH mobil EUDAMED
- Device Name
- ISC01 EUDAMED
- Model / Reference
- 3612.08 EUDAMED3602.14 EUDAMED3613.14 EUDAMED3603.10 EUDAMED3613.10 EUDAMED3612.16 EUDAMED3602.10 EUDAMED3613.16 EUDAMED3602.08 EUDAMED3613.12 EUDAMED3603.12 EUDAMED3602.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098846035 EUDAMED04250098845991 EUDAMED04250098848077 EUDAMED04250098847896 EUDAMED04250098848015 EUDAMED04250098846110 EUDAMED04250098845953 EUDAMED04250098848107 EUDAMED04250098845939 EUDAMED04250098848046 EUDAMED04250098847926 EUDAMED04250098845977 EUDAMED
- Basic UDI-DI
- 04250098810018EM EUDAMED04250098810017EK EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I 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
UROMED SIMPLYCATH mobil by UROMED Kurt Drews KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- 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
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 | 04250098810018EM | Class I | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (12)
- EUDAMED 33690289-0206-42d0-8b38-59de48b745b2 61 fields · synced Oct 6, 2026
- EUDAMED bab8d018-45b2-422f-9a4e-e4c44326e1f0 61 fields · synced May 16, 2026
- EUDAMED 037f8cf0-ebf8-4ed9-86cb-9954eb41adb0 61 fields · synced May 16, 2026
- EUDAMED 401e5205-db3d-48f6-bfd3-6401abcb5579 61 fields · synced May 17, 2026
- EUDAMED daf02e1f-1a18-4551-92fc-705e7157e1b1 61 fields · synced May 18, 2026
- EUDAMED 5be782af-178c-4ef5-8b15-06631cc1a4ae 61 fields · synced May 18, 2026
- EUDAMED 3866699f-87d0-4dee-856a-5ed626397230 61 fields · synced May 18, 2026
- EUDAMED 0317ce48-29a2-4c5d-8939-40d0722ef5bd 61 fields · synced May 18, 2026
- EUDAMED aa6a9768-d36f-4ae3-9de4-dd4f7b4ecac4 61 fields · synced May 18, 2026
- EUDAMED 06cc1232-a8d0-4793-87ca-6c25ce19bb5e 61 fields · synced May 18, 2026
- EUDAMED 68d2eb59-8c64-4827-a839-a69dfdd2bb17 61 fields · synced May 18, 2026
- EUDAMED 77dfe0ae-0c25-4a3e-b5e5-e485f4b75050 61 fields · synced May 18, 2026