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Industrial Back Support

by OPPO Medical Corp. 3 variants

Ref 2169-BK-S-1, 2169-BK-XXL-1, 2169-BK-XL-1

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471986369CL104DK Basic UDI-DI Date25 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Spine Orthoses
Model / Reference
2169-BK-S-1, 2169-BK-XXL-1, 2169-BK-XL-1
Primary DI / UDI-DI
04719863692203, 04719863692241, 04719863692234
Basic UDI-DI
471986369CL104DK
EMDN Code
Y060399 Spine orthoses - other
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
TW-MF-000005201
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from OPPO Medical Corp.

See all devices from OPPO Medical Corp. →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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