(FMlaamlein) go Gel Heel Cushion

by Ascent Meditech Limited

Ref OC-2529Model OC-2022

Withdrawn Withdrawn in European Union.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

Was authorized under CE MDR

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Withdrawn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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number081013391AMLHCV5 Basic UDI-DI 08904327016015UDI-DI	Date16 Oct 2026Registered	StatusWithdrawn 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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device name: Flamingo Heel Cushion (Pair) (Unisex)
Model / reference: OC-2022, OC-2529

Primary DI / UDI-DI: 08904327016015
Basic UDI-DI: 081013391AMLHCV5
EMDN code: Y061203 Orthoses, foot (including insoles and inserts)

Device class: Class I
EU registration type: Standard device

Manufacturer details

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

Properties

Other properties (14)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Reusable: No
Contains latex: No
Reprocessed single-use device: No
Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
Incorporates a substance derived from human blood or plasma: No
Contains human tissues or cells: No
Contains animal tissues or cells: No
Contains endocrine-disrupting substances: No
Administering medicine: No
Measuring function: No
Incorporates a medicinal substance: No