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10fg Double Lumen PVC Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 200100015Model 200100003
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 10fg Double Lumen PVC Balloon Catheter EUDAMED
- Model / Reference
- 200100003 EUDAMED200100015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166521707 EUDAMED
- Basic UDI-DI
- B-05060166521707 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
10fg Double Lumen PVC Balloon Catheter 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-05060166521707 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 31ee787d-92a5-4aa6-b6c7-e45b3567a2a4 61 fields · synced Jun 19, 2026