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Isa™ Xplus

by Invacare Portugal, Unipessoal Lda.

Ref ISAXPLUS

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5600494ISACZ Basic UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05600494138705 UDI-DIDate19 Aug 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Isa™ Xplus EUDAMED
Invacare ISA Lift GUDID
Generic Name
Mobile patient lifting system, electrically-powered
Device Name
Isa
Model / Reference
ISAXPLUS
Primary DI / UDI-DI
05600494138705
Basic UDI-DI
5600494ISACZ
FDA Product Code
FSA
EMDN Code
V0805030102 Electric mobile lifts
GMDN Term
Mobile patient lifting system, electrically-powered
Device Class
Class I
Regulation Number
880.5510
Market of Registration
Portugal
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
PT-MF-000006551

Other devices from Invacare Portugal, Unipessoal Lda.

See all devices from Invacare Portugal, Unipessoal Lda. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No