Identity
- Trade Name
- Samba Size 1 - Hi-lo Base EUDAMED
- Device Name
- Samba Size 1 - Manual Base EUDAMED
- Model / Reference
- Samba EUDAMED8811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060517534486 EUDAMED
- Basic UDI-DI
- 50564089SMUK015TE EUDAMED
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Samba Size 1 - Hi-lo Base by Smirthwaite Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50564089SMUK015TE | Class I | Active |
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Manufacturer
- Manufacturer
- Smirthwaite Limited
- EUDAMED SRN
- GB-MF-000010683
- Authorised Representative
- Evolution Healthcare Ltd XI-AR-000047925
Sources (1)
- EUDAMED 3782ef3e-e79e-464c-b604-3f0bf49f371a 61 fields · synced Jun 18, 2026