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Arjo Bariatric Loop Sling MFA8010-XL

by Arjohuntleigh, Inc.

Ref MFA8010-XLModel KKX522900L

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05059441295921 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5060693520150VT Basic UDI-DI 05059441295921UDI-DIDate16 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Sling - Disposable bariatric loop EUDAMED
Arjo Bariatric Loop Sling GUDID
Generic Name
General-purpose patient lifting system sling/harness
Device Name
Sling - Standing
Model / Ref / Catalog
MFA8010-XL, KKX522900L
Primary DI / UDI-DI
05059441295921
Basic UDI-DI
5060693520150VT
FDA Product Code
FSA
EMDN Code
V0805038002 Non-rigid supports for lifts (harnesses)
GMDN Term
General-purpose patient lifting system sling/harness
Device Class
Class I
Regulation Number
880.5510
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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