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385mm Bladder Filling Catheter 10CH
EUDAMEDClass IIa (EU MDR)
Ref 100100001Model MA101010
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 385mm Bladder Filling Catheter 10CH EUDAMED
- Model / Reference
- MA101010 EUDAMED100100001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166522506 EUDAMED
- Basic UDI-DI
- B-05060166522506 EUDAMED
- EMDN Code
- U050199 CYSTOMANOMETRY AND URETHROMANOMETRY CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
385mm Bladder Filling Catheter 10CH 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-05060166522506 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ddb6a6ad-83ff-4507-b4b4-a9b586626a73 61 fields · synced Jun 20, 2026