Identity
- Trade Name
- SILVER WAVE TOP EUDAMEDSOLIDEA FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- PREVENTIVE LINE EUDAMEDTOP, SIZE L, NERO, MICRO-MASSAGING TOP WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI
- Model / Reference
- 0494A5 EUDAMED050391 FDA UDI
- Description
- TOP, SIZE L, NERO, MICRO-MASSAGING TOP WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI
Identifiers
- Catalog Number
- 0494A5 FDA UDI
- Primary DI / UDI-DI
- 08300496050391 EUDAMEDFDA UDI
- Basic UDI-DI
- 83004960079DC23 EUDAMED
- FDA Product Code
- MDR FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Compression/pressure tubular garment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5160 FDA UDI
- Market of Registration
- Italy 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
Category: Compression/pressure tubular garment
Solidea by Calzificio Pinelli Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Calzificio Pinelli Srl
Sources (2)
- FDA UDI aa3111e9-775a-4431-8a5a-78ccf70fb768 34 fields · synced Jul 25, 2026
- EUDAMED b4b3a3d0-1a1b-4497-9064-1b863cab9a14 61 fields · synced Jul 25, 2026