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Heelift Afo

by Position Health, LLC 2 variants

Ref 831727008105

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
European UnionCE/MDR EUDAMED Number++G064R1HEELIFTFAMILY5ME Basic UDI-DI +G0648317270081050*UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+G0648317270081050* 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  • Withdrawn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

Generic Name
Ankle/foot orthosis
Device Name
Heelift
Model / Ref / Catalog
831727008105
Primary DI / UDI-DI
+G0648317270081050* EUDAMED
G0648317270081050 GUDID
Basic UDI-DI
++G064R1HEELIFTFAMILY5ME
Direct Marketing DI
+G0648317270081050*
FDA Product Code
FMP
EMDN Code
V08030102, V080399, Y06120601
GMDN Term
Ankle/foot orthosis
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
+G0648317270081050*
GUDID
G0648317270081050

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