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Silver Wave Slimming Sleeves Pro

by Calzificio Pinelli Srl EUDAMEDGUDID

Active European Union and United States

Ref 0614A5

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960080DDYU Basic UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496068716 UDI-DIDate5 Dec 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Silver Wave Slimming Sleeves Pro EUDAMED
Silver Wave Slimmin Sleeves Pro EUDAMED
Silòver Wave Slimming Sleeves Pro EUDAMED
Solidea GUDID
Generic Name
Compression/pressure tubular garment
Device Name
Therapeutic Line
Model / Ref / Catalog
0614A5, 068815, 068808, 068792, 068785, 068778, 068761, 068754, 068747, 068730, 068723, 068716, 068709, 068693, 068662, 068686, 068679
Primary DI / UDI-DI
08300496068716, 08300496068754, 08300496068686, 08300496068693, 08300496068778, 08300496068792, 08300496068785, 08300496068815, 08300496068808, 08300496068761, 08300496068747, 08300496068730, 08300496068723, 08300496068709, 08300496068662, 08300496068679
Basic UDI-DI
83004960080DDYU
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
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0614A5
GUDID
068815
068808
068792
068785
068778
068761
068754
068747
068730
068723
068716
068709
068693
068662
068686
068679
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000005917

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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