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E-Link

by Biometrics Ltd 7 variants

Ref E-LINK SW, Impairment Evaluation

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 Number506048169E-LINKY3 Basic UDI-DI 05060481692502UDI-DIDate12 Jun 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  • Withdrawn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
E-LINK Evaluation and Exercise Systems
Model / Reference
E-LINK SW, Impairment Evaluation
Primary DI / UDI-DI
05060481692502
Basic UDI-DI
506048169E-LINKY3
EMDN Code
Z12069092 Various physiotherapy and rehabilitation instruments - medical device software
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000002774
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Biometrics Ltd

See all devices from Biometrics Ltd →

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