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Single lumen rectal catheter with valved PVC balloon, 5Fr - 65mm
EUDAMEDClass IIa (EU MDR)
Ref LDRE121PLUS-20Model Rectal Catheters
Identity
- Trade Name
- Single lumen rectal catheter with valved PVC balloon, 5Fr (Ø1,65mm, L=1500mm) EUDAMED
- Model / Reference
- Rectal Catheters EUDAMEDLDRE121PLUS-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032248474161 EUDAMED
- Basic UDI-DI
- 8032248474019W EUDAMED
- Direct Marketing DI
- 08032248474161 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
Single lumen rectal catheter with valved PVC balloon, 5Fr - 65mm 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 (1)
- EUDAMED 91d35803-abe0-45da-a32e-0db4692c28dc 61 fields · synced Jun 18, 2026