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Heelift Anti-Rotation Wedge

by Position Health, LLC

Ref 831727009898

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 Number++G064R1HEELIFTFAMILY5ME Basic UDI-DI +G0648317270098980OUDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+G0648317270098980O UDI-DI Date9 Dec 2022ListedStatusListed 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  • Withdrawn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
Heelift Anti-Rotation Wedge EUDAMED
Heelift® Arw GUDID
Generic Name
Freestanding patient positioner, reusable
Device Name
Heelift
Model / Ref / Catalog
831727009898
Primary DI / UDI-DI
+G0648317270098980O EUDAMED
G0648317270098980 GUDID
Basic UDI-DI
++G064R1HEELIFTFAMILY5ME
FDA Product Code
FMP
EMDN Code
V080302 Patient positioning medical cushions
GMDN Term
Freestanding patient positioner, reusable
Device Class
Class I
Regulation Number
880.6450
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+G0648317270098980O
GUDID
G0648317270098980

Manufacturer details

EUDAMED SRN
US-MF-000009004
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Position Health, LLC

See all devices from Position Health, LLC →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No