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CoreTech

by Vive Health LLC 26 variants

Ref SUP2069BLKL

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081004198ORTHOSISELBOWNT Basic UDI-DI 00810041985491UDI-DIDate28 Oct 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  • Withdrawn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
Elbow Orthosis
Model / reference
SUP2069BLKL
Primary DI / UDI-DI
00810041985491
Basic UDI-DI
081004198ORTHOSISELBOWNT
EMDN code
Y060615 Elbow orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000050431
Authorised representative
Europecert UG (haftungsbeschränkt) DE-AR-000004974

Other devices from Vive Health LLC

See all devices from Vive Health LLC →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No