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Bladder Filling Catheter, 10fg
EUDAMEDClass IIa (EU MDR)
Ref 100100008
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Bladder Filling Catheter, 10fg EUDAMED
- Model / Reference
- 100100008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166524715 EUDAMED
- Basic UDI-DI
- B-05060166524715 EUDAMED
- EMDN Code
- U050199 CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER 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
Bladder Filling Catheter, 10fg 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-05060166524715 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED cc445e6e-4e03-47dd-9772-734d2c5c0177 61 fields · synced Oct 6, 2026