Identity
- Trade Name
- VELCRO SHEET FITTED EUDAMED
- Device Name
- SYMMETRISLEEP EUDAMED
- Model / Reference
- SA80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050962285675 EUDAMED
- Basic UDI-DI
- 5050962SYMMETRISLEEPTF EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Velcro Sheet Fitted 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 | 5050962SYMMETRISLEEPTF | Class I | Active |
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Manufacturer
- Manufacturer
- Helping Hand Company (Ledbury) Ltd
- EUDAMED SRN
- GB-MF-000011951
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (1)
- EUDAMED 00dbf94d-28ac-40df-9648-5ab42ee2e3b5 61 fields · synced Oct 6, 2026