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8fg Double Lumen UPP Catheter with Y-Connector and Tiemann Tip
EUDAMEDClass IIa (EU MDR)
Ref 100080031Ref 100080005Model 100080017
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 8fg Double Lumen UPP Catheter with Y-Connector and Tiemann Tip EUDAMED8fg Double Lumen UPP Catheter with Y-Connector EUDAMED
- Model / Reference
- 100080031 EUDAMED100080017 EUDAMED100080005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166521561 EUDAMED05060166521547 EUDAMED
- Basic UDI-DI
- B-05060166521561 EUDAMEDB-05060166521547 EUDAMED
- EMDN Code
- U05030102 URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
8fg Double Lumen UPP Catheter with Y-Connector and Tiemann Tip by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed…
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-05060166521561 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 01cf9527-f8e7-437c-a344-fdf8521a22e7 61 fields · synced Oct 7, 2026
- EUDAMED e61457a4-860c-4336-890e-898a3b8a9430 61 fields · synced May 19, 2026