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4.5fg Bladder Pressure Catheter
EUDAMEDClass IIa (EU MDR)
Ref 100045001
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 4.5fg Bladder Pressure Catheter EUDAMED
- Model / Reference
- 100045001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166521462 EUDAMED
- Basic UDI-DI
- B-05060166521462 EUDAMED
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES 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
4.5fg Bladder Pressure 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-05060166521462 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 7313caf4-7775-4c71-8a67-420dea808c1c 61 fields · synced Jun 18, 2026