Identity
- Trade Name
- SOXON EUDAMEDFDA UDI
- Generic Name
- Assistive sock/pantyhose dressing device FDA UDI
- Device Name
- SOXON EUDAMEDFDA UDI
- Model / Reference
- SOXON EUDAMEDFDA UDIHA0980 EUDAMED
- Description
- SOXON FDA UDI
Identifiers
- Catalog Number
- HA0980 FDA UDI
- Primary DI / UDI-DI
- 05050962057791 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050962SOXON33 EUDAMED
- FDA Product Code
- ILD FDA UDI
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
- GMDN Term
- Assistive sock/pantyhose dressing device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 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
Soxon 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 | 5050962SOXON33 | 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 d237ea5e-cec7-4007-b2cc-ae26204d9c4b 61 fields · synced Oct 6, 2026
- FDA UDI 8fb0e033-54cf-4964-8bab-cd8597b5f773 35 fields · synced May 30, 2026