Skip to content

Bota Ortho Elleboog 810 +silicone Wit 4

by Laboratoria Bota NV

Ref 227000440Model BOTA BRACES

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54040208BRACES6M Basic UDI-DI 05404020812486UDI-DIDate19 Aug 2026RegisteredStatusActive

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  • Withdrawn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
Bota Braces
Model / Reference
BOTA BRACES, 227000440
Primary DI / UDI-DI
05404020812486
Basic UDI-DI
54040208BRACES6M
EMDN Code
M0304010101 Elastic compression bandages, non-adhesive, low extensibility (<70%)
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000263

Other devices from Laboratoria Bota NV

See all devices from Laboratoria Bota NV →

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