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Be You Infrawave-Up

by Calzificio Pinelli Srl 13 variants

Ref 0655B5

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

CE MDR

Valid until

Not listed

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
United StatesGUDID listing GUDID Number08300496073475 UDI-DI Date15 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number83004960079DC23 Basic UDI-DI Date5 May 2026RegisteredStatusActive

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  • Withdrawn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
Be You Infrawave-Up EUDAMED
Solidea GUDID
Generic Name
Compression/pressure tubular garment
Device Name
Preventive Line
Model / Ref / Catalog
0655B5, 073697, 073666, 073642, 073475, 073444, 073437
Primary DI / UDI-DI
08300496073475, 08300496073697, 08300496073666, 08300496073642, 08300496073444, 08300496073437
Basic UDI-DI
83004960079DC23
FDA Product Code
FQL
EMDN Code
M030499 Elastic bandages, support and compression - other
GMDN Term
Compression/pressure tubular garment
Device Class
Class I
Regulation Number
880.5780
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0655B5
GUDID
073697
073666
073642
073475
073444
073437

Manufacturer details

EUDAMED SRN
IT-MF-000005917

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 (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No