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Double-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr, - 96
EUDAMEDClass IIa (EU MDR)
Ref ADRE122Model Rectal Catheters - containing LATEXRef UD-CPR121/MRef DRE122-10Ref UD-CPR091Ref MBP4421Ref UD-CPR121Ref MBP4391M
Identity
- Trade Name
- Double-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr, (Ø3,96, L=200mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr (Ø3,96mm, L=300mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with latex balloon, 12Fr(Ø3,96mm, L=190mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with latex balloon, 9Fr (Ø2,97mm, L=150mm) EUDAMEDDouble-lumen rectal catheter for urodynamic examination with latex balloon, 9Fr (Ø2,97mm, L=200mm) EUDAMED
- Model / Reference
- Rectal Catheters - containing LATEX EUDAMEDADRE122 EUDAMEDUD-CPR121/M EUDAMEDDRE122-10 EUDAMEDUD-CPR091 EUDAMEDMBP4421 EUDAMEDUD-CPR121 EUDAMEDMBP4391M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032248476523 EUDAMED08032248476660 EUDAMED08032248476714 EUDAMED08032248476639 EUDAMED08032248476585 EUDAMED08032248476653 EUDAMED08032248476561 EUDAMED
- Basic UDI-DI
- 803224847651AP EUDAMED
- Direct Marketing DI
- 08032248476523 EUDAMED08032248476660 EUDAMED08032248476714 EUDAMED08032248476639 EUDAMED08032248476585 EUDAMED08032248476653 EUDAMED08032248476561 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
Yes
EUDAMEDEUDAMED
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 latex balloon, 12Fr, - 96 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 | 803224847651AP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (7)
- EUDAMED 66f61548-6fbd-4a29-9923-42cd8505a797 61 fields · synced Jul 31, 2026
- EUDAMED 982263df-4a21-49db-a074-a3698c5f9cf3 61 fields · synced May 17, 2026
- EUDAMED 2fe10e8f-73eb-4d36-b6ab-b14dd0fb2972 61 fields · synced May 17, 2026
- EUDAMED 6ee5bce2-8e6f-4862-b02b-2571b6eab280 61 fields · synced May 17, 2026
- EUDAMED e20f0f0a-6b5b-4995-8e66-0a13f1d8d7fa 61 fields · synced May 17, 2026
- EUDAMED 6bbf008f-3bb9-4cac-9134-8043df0913ef 61 fields · synced May 18, 2026
- EUDAMED 6d435534-71bd-4385-88d3-360a1dd8bce2 61 fields · synced May 18, 2026