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Solidea 40347

by Calzificio Pinelli SRL

Ref 0418A8

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960080DDYU Basic UDI-DI 08300496040347UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496040347 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Wonder Model CCL.1 EUDAMED
Solidea GUDID
Generic name
Compression/pressure sock/stocking, reusable
Device name
Therapeutic Line
Model / Ref / Catalog
0418A8, 40347
Primary DI / UDI-DI
08300496040347
Basic UDI-DI
83004960080DDYU
FDA product code
DWL
EMDN code
M030499 Elastic bandages, support and compression - other
GMDN term
Compression/pressure sock/stocking, reusable
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
0418A8
GUDID
40347
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Compression/pressure sock/stocking, reusable

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)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No