579 Melany Donning & Doffing Large
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MELANY EUDAMED579 Melany Donning & Doffing Large FDA UDI
- Generic Name
- Assistive sock/pantyhose dressing device FDA UDI
- Device Name
- A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI
- Model / Reference
- 309389 EUDAMEDFDA UDIMELANY EUDAMED
- Description
- A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI
Identifiers
- Catalog Number
- 579MLG FDA UDI
- Primary DI / UDI-DI
- 07613378105326 EUDAMEDFDA UDI
- Basic UDI-DI
- 7613378MELANYZ5 EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- M030405 COMPRESSION STOCKINGS 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Assistive sock/pantyhose dressing device
579 Melany Donning & Doffing Large by Sigvaris, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sigvaris, Inc.
Sources (2)
- FDA UDI a15abf22-164e-4398-9953-726bd4f87730 36 fields · synced Jul 18, 2026
- EUDAMED cf77edec-3070-4d87-8b72-bb99c48dae09 61 fields · synced Jul 18, 2026