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Double Lumen Cystometry Catheter, 8Fr
EUDAMEDClass IIa (EU MDR)
Ref 100080003Model 100080015
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Double Lumen Cystometry Catheter, 8Fr EUDAMED
- Model / Reference
- 100080015 EUDAMED100080003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166521523 EUDAMED
- Basic UDI-DI
- B-05060166521523 EUDAMED
- EMDN Code
- U05010101 CYSTOMANOMETRY 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
Double Lumen Cystometry Catheter, 8Fr 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-05060166521523 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 10a3c214-8ae1-4d2c-b2a5-8901085e95e6 61 fields · synced Jun 18, 2026