Identity
- Trade Name
- BE YOU TONIC PRO EUDAMEDSOLIDEA FDA UDI
- Generic Name
- Compression/pressure sock/stocking, reusable FDA UDI
- Device Name
- THERAPEUTIC LINE EUDAMEDBE YOU TONIC PRO, SIZE XL, RIBES, GRADUATED COMPRESSION 15/21 mmHg OPAQUE MICRO-MASSAGING LEGGINGS WITH A THREE-DIMENSIONAL CONSTRUCTION AND OPEN TOE FOR OUTDOOR USE FDA UDI
- Model / Reference
- 0615B5 EUDAMED070511 FDA UDI
- Description
- BE YOU TONIC PRO, SIZE XL, RIBES, GRADUATED COMPRESSION 15/21 mmHg OPAQUE MICRO-MASSAGING LEGGINGS WITH A THREE-DIMENSIONAL CONSTRUCTION AND OPEN TOE FOR OUTDOOR USE FDA UDI
Identifiers
- Catalog Number
- 0615B5 FDA UDI
- Primary DI / UDI-DI
- 08300496070511 EUDAMEDFDA UDI
- Basic UDI-DI
- 83004960080DDYU EUDAMED
- FDA Product Code
- FQL FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Compression/pressure sock/stocking, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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 sock/stocking, reusable
Solidea by Calzificio Pinelli Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, reusable.
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- JOBST Style — BSN MEDICAL, INC. · Class II
- Female compression bodystocking — Eto Garments ApS · 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 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 431068ad-09f6-4875-898e-deb88c2bce6c 34 fields · synced Jul 25, 2026
- EUDAMED 5d49ef60-e601-4478-8b0d-6d144496641d 61 fields · synced Jul 25, 2026