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AxonEnergy Integral

by Otto Bock Healthcare Products GmbH

Ref 757B501

AxonEnergy Integral (757B501) is a Class I device made by Otto Bock Healthcare Products GmbH, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 40644110000000757B501QR), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40644110000000757B501QR Basic UDI-DI 04064411255738UDI-DIDate29 Oct 2026RegisteredStatusActive

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  • Withdrawn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

Model / reference
757B501
Primary DI / UDI-DI
04064411255738
Basic UDI-DI
40644110000000757B501QR
EMDN code
Y061899 Upper extremity prostheses - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AT-MF-000002920

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Properties

Other properties (14, all answered No)