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Solidea

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 0353A5

by Calzificio Pinelli Srl

Identity

Trade Name
SILVER WAVE SHORT EUDAMED
SOLIDEA FDA UDI
Generic Name
Compression/pressure tubular garment FDA UDI
Device Name
PREVENTIVE LINE EUDAMED
SHORT, SIZE XL, NOISETTE, MICRO-MASSAGING SHORTS WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI
Model / Reference
0353A5 EUDAMED
029212 FDA UDI
Description
SHORT, SIZE XL, NOISETTE, MICRO-MASSAGING SHORTS WITH A THREE-DIMENSIONAL CONSTRUCTION FDA UDI

Identifiers

Catalog Number
0353A5 FDA UDI
Primary DI / UDI-DI
08300496029212 EUDAMEDFDA UDI
Basic UDI-DI
83004960079DC23 EUDAMED
FDA Product Code
FQL 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
880.5780 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 I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Compression/pressure tubular garment.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 3127c22e-f077-44bb-98e0-b9b8bd5258fd 34 fields · synced Jun 19, 2026
  • EUDAMED 2fac6bdf-dfcc-4982-b7a8-39633b5b0781 61 fields · synced Jun 19, 2026