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Elbow Support

by OPPO Medical Inc. 20 variants

Ref 2080-BG-XL, 2986-GY-XXXL, 1080-BK-S, 1085-BG-XL, 2080-BG-L, 2385-R-GY-L, 2385-L-GY-S, 1085-BG-M, 1080-BK-XL, 2986-GY-XL, RE200-BK-M, 1080-BG-L, 2587-BG-L, 2385-L-GY-M, 2385-R-GY-XL, 2986-GY-XXL, 2080-BG-S, 1080-BG-M, 2085-BG-XL, 2385-R-GY-S, 2986-GY-S, 2080-BG-M, 1080-BK-L, 2986-GY-L

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 Number08402706CL1034P Basic UDI-DI Date12 Sep 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  • Withdrawn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
Upper Extremity Orthoses
Model / Reference
2080-BG-XL, 2986-GY-XXXL, 1080-BK-S, 1085-BG-XL, 2080-BG-L, 2385-R-GY-L, 2385-L-GY-S, 1085-BG-M, 1080-BK-XL, 2986-GY-XL, RE200-BK-M, 1080-BG-L, 2587-BG-L, 2385-L-GY-M, 2385-R-GY-XL, 2986-GY-XXL, 2080-BG-S, 1080-BG-M, 2085-BG-XL, 2385-R-GY-S, 2986-GY-S, 2080-BG-M, 1080-BK-L, 2986-GY-L
Primary DI / UDI-DI
00840270603064, 00840270621754, 00840270611076, 00840270601121, 00840270603057, 00840270614787, 00840270614800, 00840270601107, 00840270611113, 00840270621808, 00840270628371, 00840270600964, 00840270606768, 00840270614817, 00840270614794, 00840270621815, 00840270603033, 00840270600957, 00840270603255, 00840270614763, 00840270621778, 00840270603040, 00840270611106, 00840270621792
Basic UDI-DI
08402706CL1034P
EMDN Code
Y060699 Orthoses, upper extremity - other
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000005202
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Contains Latex YesEUDAMEDNoEUDAMED

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