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Double-lumen rectal catheter for urodynamic examination with silicone balloon, 9Fr - 97mm
EUDAMEDClass IIa (EU MDR)
Ref MBP4591MModel Rectal CathetersRef MBP4621Ref MBP4621MRef MBP4591Ref ADRE092Ref DRE092-10Ref UD-CPR121/S
Identity
- Trade Name
- Double-lumen rectal catheter for urodynamic examination with silicone balloon, 9Fr (Ø2,97mm, L=200mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96mm, L=300mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96mm, L=300mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with silicone balloon, 9Fr (Ø2,97mm, L=150mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with silicone balloon, 9Fr (Ø2,97mm, L=150mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with silicone balloon, 12Fr (Ø3,96, L=300mm) EUDAMED
- Model / Reference
- Rectal Catheters EUDAMEDMBP4591M EUDAMEDMBP4621 EUDAMEDMBP4621M EUDAMEDMBP4591 EUDAMEDADRE092 EUDAMEDDRE092-10 EUDAMEDUD-CPR121/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032248474055 EUDAMED08032248474079 EUDAMED08032248474062 EUDAMED08032248474048 EUDAMED08032248474123 EUDAMED08032248474130 EUDAMED08032248474093 EUDAMED
- Basic UDI-DI
- 8032248474019W EUDAMED
- Direct Marketing DI
- 08032248474055 EUDAMED08032248474079 EUDAMED08032248474062 EUDAMED08032248474048 EUDAMED08032248474123 EUDAMED08032248474130 EUDAMED08032248474093 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa 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
Double-lumen rectal catheter for urodynamic examination with silicone balloon, 9Fr - 97mm by Delta Med Spa — Class IIa — MDR — listed in EUDAMED — 3 models
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 | 8032248474019W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (7)
- EUDAMED d241145e-7fa1-45b8-a120-2d4c9549ef7e 61 fields · synced Aug 3, 2026
- EUDAMED 5cb5a924-cb3b-43ea-b1e6-1e4e554a76ca 61 fields · synced May 17, 2026
- EUDAMED e5f694a8-dbcb-4cbe-be14-ac6dd09ea6f8 61 fields · synced May 17, 2026
- EUDAMED 431a8446-d3c7-4349-8450-12a393244200 61 fields · synced May 17, 2026
- EUDAMED d7da86f7-f3b9-49d6-82a8-348345fe7808 61 fields · synced May 18, 2026
- EUDAMED 33121212-dce7-4ad7-b927-147da0056c80 61 fields · synced May 18, 2026
- EUDAMED 3e54f55e-06d8-4d57-86ae-f1bd80994380 61 fields · synced May 18, 2026