Identity
- Trade Name
- SA5535REU EUDAMED
- Device Name
- PRIMO STARTER PACK EU EUDAMED
- Model / Reference
- PR2018EU EUDAMEDSA5535REU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050962476806 EUDAMED
- Basic UDI-DI
- 5050962SYMMETRISLEEPPKJY EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- PROVIDING TARGETED SUPPORT FOR THE USER EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Sa5535reu by Helping Hand Company (Ledbury) 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 | 5050962SYMMETRISLEEPPKJY | Class I | Active |
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Manufacturer
- Manufacturer
- Helping Hand Company (Ledbury) Ltd
- EUDAMED SRN
- UK-PR-000052099
Sources (1)
- EUDAMED a727998d-c684-4012-93ae-1bdb48a66bbc 61 fields · synced Jul 20, 2026