Identity
- Trade Name
- UROMED SIMPLYCATH mobil Trial Set »pouch« EUDAMED
- Device Name
- ISC01 EUDAMED
- Model / Reference
- 3615.16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098835855 EUDAMED
- Basic UDI-DI
- 04250098810019EP 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 Trial Set »pouch« by UROMED Kurt Drews KG — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
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- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
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 | 04250098810019EP | Class I | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 042bbb41-6f29-4b55-aac3-5edf31d967f0 61 fields · synced Oct 6, 2026