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Pump Guard
EUDAMEDClass IIa (EU MDR)
Ref 400100005
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- Pump Guard EUDAMED
- Model / Reference
- 400100005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166524609 EUDAMED
- Basic UDI-DI
- B-05060166524609 EUDAMED
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES 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
Pump 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-05060166524609 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e71fe9fa-8857-4eb5-816f-d43abe002cd3 61 fields · synced Jul 10, 2026