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Bladder Filling Catheter, 8fg
EUDAMEDClass IIa (EU MDR)
Ref 100080014
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Bladder Filling Catheter, 8fg EUDAMED
- Model / Reference
- 100080014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166524708 EUDAMED
- Basic UDI-DI
- B-05060166524708 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, 8fg 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-05060166524708 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 17db1ecf-cb7a-4216-87ee-e0282b80ea81 61 fields · synced Oct 6, 2026