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Flexitol 25% Urea Heel Balm

by Thornton & Ross Ltd 2 variants

Ref 178564 (500g Rx)Model Flexitol Cracked Heel Balm OTC

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5011309SkinTreatmentDF Basic UDI-DI 05011309105216UDI-DIDate4 May 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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Flexitol Heel Balm
Model / Reference
Flexitol Cracked Heel Balm OTC, 178564 (500g Rx)
Primary DI / UDI-DI
05011309105216
Basic UDI-DI
5011309SkinTreatmentDF
Direct Marketing DI
05011309105216
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class IIa
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000009462
Authorised representative
HÄLSA Pharma GmbH DE-AR-000007406

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Properties

Other properties (13)

  • 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