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Flamingo Premium Silicone Stress Ball (Soft-Yellow / Medium-Red / Hard-Blue)

by Ascent Meditech Limited

Ref OC-2393Model OC-2138

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 Number081013391AMLAIUU Basic UDI-DI 08904327001219UDI-DIDate16 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Flamingo Gel Exercise Ball (Soft-Yellow / Medium-Red / Hard-Blue)
Model / Reference
OC-2138, OC-2393
Primary DI / UDI-DI
08904327001219
Basic UDI-DI
081013391AMLAIUU
EMDN Code
Y0503 Hands and fingers re-education devices
Device Class
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000039228
Authorised representative
Mars Medical DE-AR-000006312

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