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Scott-Stops B Size

by Becker Orthopedic Appliance Company

Part of a family of 228 devices: see the family page

Ref SC-43BModel 1009

Scott-Stops B Size (SC-43B) is a Class I device made by Becker Orthopedic Appliance Company, registered in EUDAMED on 10 Jan 2022 (Basic UDI-DI 194545100976), 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 Number194545100976 Basic UDI-DI 00194545021399UDI-DIDate10 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  • Withdrawn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
Polycentric Free Motion Knee Joint
Model / reference
1009, SC-43B
Primary DI / UDI-DI
00194545021399
Basic UDI-DI
194545100976
EMDN code
Y061209 Knee orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

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

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Properties

Other properties (14, all answered No)