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Silver Support Ankle

by Calzificio Pinelli Srl EUDAMEDGUDID

Active European Union

Ref 0392B8

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number83004960079DC23 Basic UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08300496036418 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  • Withdrawn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 Ankle EUDAMED
Solidea GUDID
Generic Name
Compression/pressure tubular garment
Device Name
Preventive Line
Model / Ref / Catalog
0392B8, 036418, 036388, 036401, 036364, 036340, 036333, 036326, 036302, 036289
Description
SUPPORT ANKLE, SIZE XL, CAMEL, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE M, CAMEL, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE L, CAMEL, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE XL, NERO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE ML, NERO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE M, NERO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE S, NERO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE L, BIANCO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
SUPPORT ANKLE, SIZE M, BIANCO, GRADUATED COMPRESSION 23/32 mmHg ANKLE SUPPORT
Primary DI / UDI-DI
08300496036418, 08300496036388, 08300496036401, 08300496036364, 08300496036340, 08300496036333, 08300496036326, 08300496036302, 08300496036289
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
0392B8
GUDID
036418
036388
036401
036364
036340
036333
036326
036302
036289
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