Identity
- Trade Name
- hi-slip plus EUDAMED
- Device Name
- Single use hydrophilic urinary catheter for intermittent urinary catheterization EUDAMED
- Model / Reference
- TRHSPF1516B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387001029 EUDAMED
- Basic UDI-DI
- 733338724101CV EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
hi-slip plus by Wellspect HealthCare — 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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- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- HOMECATH — İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi · Class IIa
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 | 733338724101CV | Class I | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (2)
- EUDAMED d05ab87c-9e2a-4d0b-97df-8c051ccfd01c 61 fields · synced Oct 6, 2026
- EUDAMED f2585a01-acba-48b4-97df-48ec52cc72ae 61 fields · synced Jul 17, 2026