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Rectal Split Balloon Catheter, 4.5fr
EUDAMEDClass IIa (EU MDR)
Ref 200045019Model U050402
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Rectal Split Balloon Catheter, 4.5fr EUDAMED
- Model / Reference
- U050402 EUDAMED200045019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166524678 EUDAMED
- Basic UDI-DI
- B-05060166524678 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rectal Split Balloon Catheter, 4.5fr by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060166524678 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 0fbf5948-22e7-4b23-8e1c-5fd7683be7f5 61 fields · synced Jun 19, 2026