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SensaCath Aqua intermittent catheter with hydrophilic coating, tiemann tip, non…
EUDAMEDClass I (EU MDR)
Ref AQUAT16
Identity
- Trade Name
- SensaCath Aqua intermittent catheter with hydrophilic coating, tiemann tip, non-touch slider and water sachet, standard length 40cm, CH16 EUDAMED
- Device Name
- Intermittent catheter EUDAMED
- Model / Reference
- AQUAT16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05036100009310 EUDAMED
- Basic UDI-DI
- 50361000ISC1C3 EUDAMED
- EMDN Code
- U01010601 TIEMANN CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
SensaCath Aqua intermittent catheter with hydrophilic coating, tiemann tip, non… by Clinisupplies Ltd — Class I — MDR — listed in EUDAMED
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 | 50361000ISC1C3 | Class I | Active |
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Manufacturer
- Manufacturer
- Clinisupplies Ltd
- EUDAMED SRN
- GB-MF-000023783
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED d759a926-f819-4ec6-9d3e-b4344e253d0d 61 fields · synced Jun 19, 2026