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Solidea 037057

by Calzificio Pinelli SRL

Ref 0394A5

Solidea 037057 (0394A5) is a device classified as Class I in the EU and Class II in the US made by Calzificio Pinelli SRL, registered in EUDAMED on 5 May 2026 (Basic UDI-DI 83004960079DC23) and listed in FDA GUDID since 4 Jun 2025 (UDI-DI 08300496037057), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960079DC23 Basic UDI-DI 08300496037057UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496037057 UDI-DI Date4 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 83004960079DC23 registered 5 May 2026 Active
  • FDA GUDID UDI-DI 08300496037057 listed 4 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08300496037057
  2. Registered EUDAMED 83004960079DC23

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Silver Wave Abdominal Band EUDAMED
Solidea GUDID
Generic name
Compression/pressure tubular garment
Device name
Preventive Line
Model / Ref / Catalog
0394A5, 037057
Primary DI / UDI-DI
08300496037057
Basic UDI-DI
83004960079DC23
FDA product code
DWL
EMDN code
M030499 Elastic bandages, support and compression - other
GMDN term
Compression/pressure tubular garment
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5780
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0394A5
GUDID
037057
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Compression/pressure tubular garment

Similar devices in this category

Other devices filed under ELASTIC BANDAGES, SUPPORT AND COMPRESSION.

Other devices from Calzificio Pinelli SRL

See all devices from Calzificio Pinelli SRL →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)