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Juditta-36 B60, Tappezzeria Grigio Scuro E Telaio Nero

by ORMESA S.r.l.

Ref 62Model JUDITTA

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08055715701805 UDI-DI Date27 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805571570JUDIG8 Basic UDI-DI 08055715701805UDI-DIDate16 Jul 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  • Withdrawn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
Juditta-36 B60, Tappezzeria Grigio Scuro E Telaio Nero EUDAMED
Juditta GUDID
Generic Name
Push-rim manual wheelchair, non-bariatric
Model / Reference
JUDITTA EUDAMED
62 EUDAMED
JUDITTA-36 B60 GUDID
TAPPEZZERIA GRIGIO SCURO E TELAIO NERO GUDID
Primary DI / UDI-DI
08055715701805
Basic UDI-DI
805571570JUDIG8
FDA Product Code
INM
EMDN Code
Y180918 Multifunctional chairs
GMDN Term
Push-rim manual wheelchair, non-bariatric
Device Class
Class I
Regulation Number
890.3100
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
JUDITTA
62
GUDID
JUDITTA-36 B60, TAPPEZZERIA GRIGIO SCURO E TELAIO NERO

Manufacturer details

EUDAMED SRN
IT-MF-000034824

Other devices from ORMESA S.r.l.

See all devices from ORMESA S.r.l. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No