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Flamingo Pediatric Dorsolumbar Spinal Brace

by Ascent Meditech Limited

Ref OC-2034, OC-2210, OC-2129, OC-2361, OC-2363Model OC-2034

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081013391AMLBPSV8 Basic UDI-DI 08906008302349UDI-DIDate23 Sep 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  • Withdrawn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European Union — CE/MDR Withdrawn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 Dorsolumbar Spinal Brace (Taylors Brace)
Model / Reference
OC-2034, OC-2210, OC-2129, OC-2361, OC-2363
Primary DI / UDI-DI
08906008302349
Basic UDI-DI
081013391AMLBPSV8
EMDN Code
Y060309 Thoracolumbosacral spine orthoses
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