Product
T-Control®
T-Control® is an indwelling urinary catheter with an integrated flow-control valve designed to support controlled urinary drainage and simplify catheter management.
Concept
A catheter with an integrated flow-control valve
Conventional indwelling catheters drain the bladder continuously into a bag. The integrated valve of T-Control® allows controlled bladder filling and emptying rather than continuous free drainage when clinically appropriate, and the catheter can also be connected to a urine drainage bag for continuous drainage when clinically indicated.
- Device typeIndwelling urethral catheter
- MDR classificationClass IIb
- Regulatory statusCE marked under Regulation (EU) 2017/745
- Notified BodyTÜV SÜD Product Service GmbH — NB 0123
Design characteristics
What the design addresses
Drainage management
- Integrated flow control with fewer handling steps
- Controlled or intermittent drainage when clinically appropriate
- Compatible with a urine drainage bag for continuous drainage when clinically indicated
Insertion and handling
- Controlled insertion with integrated flow management
- Designed to support aseptic catheterisation technique
- Fewer manipulations of the drainage circuit
Evaluation in progress
- Comparative in-vitro biofilm study completed
- MDR clinical evaluation and post-market clinical follow-up (PMCF) ongoing
- Potential impact on consumable use is being evaluated
Regulatory information
- Device
- T-Control® urethral catheter
- Classification
- Medical Device — Class IIb
- Regulation
- Regulation (EU) 2017/745
- CE marking
- CE 0123
- Notified Body
- TÜV SÜD Product Service GmbH
- Legal manufacturer
- Rethink Medical S.L.
Instructions for Use — Revision 1, July 2026. View Instructions for Use
Availability is subject to local regulatory requirements. T-Control® is not cleared for sale in the United States.