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Stirrup Ankle Brace

by I Caremed Co., Ltd.

Ref AE009

Stirrup Ankle Brace (AE009) is a Class I device made by I Caremed Co., Ltd., registered in EUDAMED on 16 Sep 2022 (Basic UDI-DI 47510984AE009BQ), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47510984AE009BQ Basic UDI-DI 04715109841084UDI-DIDate16 Sep 2022RegisteredStatusActive

Official records

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  • Withdrawn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

Trade name
Stirrup Ankle Brace
Icare
Device name
Bracing & Support
Model / reference
AE009
Primary DI / UDI-DI
04715109841084
Basic UDI-DI
47510984AE009BQ, 471510984AE009XG
Direct marketing DI
04715109841084
EMDN code
Y06120601 Passive ankle-foot orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
France
Netherlands

Manufacturer details

EUDAMED SRN
TW-MF-000028317
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Related devices

Category: Ankle/foot orthosis

Similar devices in this category

Other devices filed under PASSIVE ANKLE-FOOT ORTHOSES.

Other devices from I Caremed Co., Ltd.

See all devices from I Caremed Co., Ltd. →

Properties

Other properties (14, all answered No)