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Silver Support Wrist

by Calzificio Pinelli Srl EUDAMEDGUDID

Active European Union

Ref 0391B8

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960079DC23 Basic UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496036197 UDI-DIDate8 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Silver Support Wrist EUDAMED
Solidea GUDID
Generic Name
Compression/pressure tubular garment
Device Name
Preventive Line
Model / Ref / Catalog
0391B8, 036784, 036777, 036760, 036753, 036746, 036722, 036227, 036210, 036203, 036197, 036180, 036166, 036159
Primary DI / UDI-DI
08300496036197, 08300496036180, 08300496036784, 08300496036777, 08300496036760, 08300496036753, 08300496036746, 08300496036722, 08300496036227, 08300496036210, 08300496036203, 08300496036173, 08300496036159
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
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0391B8
GUDID
036784
036777
036760
036753
036746
036722
036227
036210
036203
036197
036180
036166
036159
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000005917

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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