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Malleo Promaster Aktiv

by Thuasne Deutschland GmbH 12 variants

Ref T35022220201102

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 Number4035459DE0901C4B Basic UDI-DI 04035459320214UDI-DIDate8 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Malleo Promaster Aktiv
Model / Reference
T35022220201102
Primary DI / UDI-DI
04035459320214
Basic UDI-DI
4035459DE0901C4B
Direct Marketing DI
04035459320214
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000006210

Related devices

Category: Ankle/foot orthosis

Other devices from Thuasne Deutschland GmbH

See all devices from Thuasne Deutschland GmbH →

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