Identity
- Trade Name
- SILVER WAVE ABDOMINAL BAND EUDAMEDSOLIDEA FDA UDI
- Generic Name
- Compression/pressure tubular garment FDA UDI
- Device Name
- PREVENTIVE LINE EUDAMEDABDOMINAL BAND, SIZE S, NOISETTE, MICRO-MASSAGING ADBOMINAL BAND WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI
- Model / Reference
- 0394A5 EUDAMED037057 FDA UDI
- Description
- ABDOMINAL BAND, SIZE S, NOISETTE, MICRO-MASSAGING ADBOMINAL BAND WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI
Identifiers
- Catalog Number
- 0394A5 FDA UDI
- Primary DI / UDI-DI
- 08300496037057 EUDAMEDFDA UDI
- Basic UDI-DI
- 83004960079DC23 EUDAMED
- FDA Product Code
- DWL 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5780 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 II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure tubular garment.
- Vive — VIVE HEALTH LLC · Class I
- Optiform Flex — SIGVARIS, INC. · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class II
- Copperfit — IDEAVILLAGE PRODUCTS CORP. · Class I
- Optiform Hold — SIGVARIS, INC. · Class I
- Vive — VIVE HEALTH LLC · Class I
- AeroWrap Thigh Small Right — SUN-SCIENTIFIC INC. · Class I
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Calzificio Pinelli Srl
Sources (2)
- FDA UDI 8a2072e0-981b-42e6-a871-8b2723dd32a7 34 fields · synced Jun 19, 2026
- EUDAMED 3c4a0ebb-6cb8-42da-abfb-bc99d3c7c62c 61 fields · synced Jun 19, 2026