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Solidea 005537

by Calzificio Pinelli SRL

Ref 022570

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960079DC23 Basic UDI-DI 08300496005537UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496005537 UDI-DI Date17 Apr 2020ListedStatusListed 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  • Withdrawn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
Relax 70 Unisex EUDAMED
Solidea GUDID
Generic name
Compression/pressure sock/stocking, reusable
Device name
Preventive Line
Model / Ref / Catalog
022570, 005537
Primary DI / UDI-DI
08300496005537
Basic UDI-DI
83004960079DC23
FDA product code
FQL
EMDN code
M030499 Elastic bandages, support and compression - other
GMDN term
Compression/pressure sock/stocking, reusable
Device class
Class I
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 · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
022570
GUDID
005537

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