Double-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr(Ø3, 96mm, L=190mm)
by Delta Med SPA Italy EUDAMED
Ref DRE122-10Model Rectal Catheters - containing LATEX
EMDN U050402
Overview
This double-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr(Ø3,96mm, L=190mm), is a medical device used to collect diagnostic data on bladder function. It features a unique latex balloon that expands during the procedure, providing a detailed visualization of the urinary tract. The device has been designed with human product and instrument specifications in mind, ensuring compatibility with various medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803224847651AP | Date4 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Rectal Catheters - containing LATEX, DRE122-10
- Primary DI / UDI-DI
- 08032248476714
- Basic UDI-DI
- 803224847651AP
- Direct Marketing DI
- 08032248476714
- EMDN Code
- U050402 Intra-abdominal pressure measurement catheters, with balloon
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- IT-MF-000027962
Other devices from Delta Med SpA
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 2fe10e8f-73eb-4d36-b6ab-b14dd0fb2972