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OppO genu X

by OPPO Medical Inc. 25 variants

Ref 2935-R-L-O-BK-XL, 2935-R-R-O-BK-XXL, 2935-R-L-O-BK-S, 2935-C-L-I-BK-M, 2935-R-R-I-BK-XL, 2935-C-L-O-BK-S, 2935-R-R-O-BK-XS, 2935-C-R-I-BK-S, 2935-R-R-I-BK-L, 2935-R-L-O-BK-L, 2935-R-R-I-BK-S, 2935-R-L-I-BK-S, 2935-R-L-O-BK-M, 2935-C-R-I-BK-M, 2935-C-L-O-BK-XL, 2935-R-L-I-BK-M, 2935-R-R-O-BK-L, 2935-C-R-I-BK-XL, 2935-R-R-O-BK-XXXL, 2935-R-R-I-BK-XS, 2935-C-R-O-BK-S, 2935-C-L-O-BK-XXL, 2935-C-L-I-BK-S, 2935-R-R-O-BK-M, 2935-R-R-I-BK-M, 2935-C-R-O-BK-M, 2935-R-R-I-BK-XXXL, 2935-C-L-I-BK-XXXL

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 Number08402706CL1134S Basic UDI-DI Date5 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  • Withdrawn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
Knee Orthoses
Model / Reference
2935-R-L-O-BK-XL, 2935-R-R-O-BK-XXL, 2935-R-L-O-BK-S, 2935-C-L-I-BK-M, 2935-R-R-I-BK-XL, 2935-C-L-O-BK-S, 2935-R-R-O-BK-XS, 2935-C-R-I-BK-S, 2935-R-R-I-BK-L, 2935-R-L-O-BK-L, 2935-R-R-I-BK-S, 2935-R-L-I-BK-S, 2935-R-L-O-BK-M, 2935-C-R-I-BK-M, 2935-C-L-O-BK-XL, 2935-R-L-I-BK-M, 2935-R-R-O-BK-L, 2935-C-R-I-BK-XL, 2935-R-R-O-BK-XXXL, 2935-R-R-I-BK-XS, 2935-C-R-O-BK-S, 2935-C-L-O-BK-XXL, 2935-C-L-I-BK-S, 2935-R-R-O-BK-M, 2935-R-R-I-BK-M, 2935-C-R-O-BK-M, 2935-R-R-I-BK-XXXL, 2935-C-L-I-BK-XXXL
Primary DI / UDI-DI
00840270604498, 00840270604658, 00840270604467, 00840270602708, 00840270602289, 00840270605068, 00840270604566, 00840270602753, 00840270602180, 00840270604481, 00840270602166, 00840270601855, 00840270604474, 00840270602760, 00840270605099, 00840270602104, 00840270604597, 00840270602784, 00840270604665, 00840270602159, 00840270605198, 00840270605174, 00840270602319, 00840270604580, 00840270602173, 00840270605204, 00840270602302, 00840270602746
Basic UDI-DI
08402706CL1134S
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

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

Other devices from OPPO Medical Inc.

See all devices from OPPO Medical Inc. →

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