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Lever 1011

by Becker Orthopedic Appliance Company

Part of a family of 67 devices: see the family page

Ref 1011A45, 1011B45Model 1011

Lever 1011 (1011A45) is a Class I device made by Becker Orthopedic Appliance Company, registered in EUDAMED on 11 Jan 2022 (Basic UDI-DI 19454510116R), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number19454510116R Basic UDI-DI Date11 Jan 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  • Withdrawn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

Device name
Automatic Trigger Lock Knee Joint
Model / reference
1011, 1011A45, 1011B45
Primary DI / UDI-DI
00194545070625, 00194545070632
Basic UDI-DI
19454510116R
EMDN code
Y06121201 Passive knee-ankle-foot orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000004002
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

Other devices filed under KNEE-ANKLE-FOOT ORTHOSES.

Other devices from Becker Orthopedic Appliance Company

See all devices from Becker Orthopedic Appliance Company →

Properties

Other properties (14, all answered No)