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Set Guard
EUDAMEDClass IIa (EU MDR)
Ref 400100005
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Set Guard EUDAMED
- Model / Reference
- 400100005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166525842 EUDAMED
- Basic UDI-DI
- B-05060166525842 EUDAMED
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Set Guard by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05060166525842 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 18bc6b5b-d822-4d5f-88ed-1222eba6c930 61 fields · synced Oct 6, 2026