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Neoprene Thigh Support

by Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

Ref REF-500-SModel REF-500

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, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86825110ER550HW Basic UDI-DI 08682511005563UDI-DIDate1 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
REF-500, REF-500-S
Primary DI / UDI-DI
08682511005563
Basic UDI-DI
86825110ER550HW
EMDN Code
Y061218 Hip-knee-ankle-foot orthoses
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000044533

Other devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ersa Med Medi̇kal Ve Ortopedi̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

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