Identity
- Trade Name
- SYMMETRISLEEP SPECIALS EUDAMEDSLEEP SYSTEM NITETIME FDA UDI
- Generic Name
- Assistive sleeping cushion set FDA UDI
- Device Name
- SYMMETRISLEEP EUDAMEDSLEEP SYSTEM NITETIME FDA UDI
- Model / Reference
- SA79 EUDAMED'A' CUSHION_SPECIAL FDA UDI
- Description
- SLEEP SYSTEM NITETIME FDA UDI
Identifiers
- Catalog Number
- SA79 FDA UDI
- Primary DI / UDI-DI
- 05050962013520 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050962SYMMETRISLEEPTF EUDAMED
- FDA Product Code
- FNJ FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Assistive sleeping cushion set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5120 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Symmetrisleep Specials by Helping Hand Company (Ledbury) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5050962SYMMETRISLEEPTF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 8229fe55-41aa-4070-8541-68d98f359cfd 61 fields · synced Jul 9, 2026
- FDA UDI 78644d6c-eb50-4681-a08d-c80680f8d9f4 35 fields · synced May 30, 2026