Skip to content

Lumbar Spine Orthosis

by Fung Lead Medical & Sports Co., Ltd. 3 variants

Ref E313

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988344003HS Basic UDI-DI 04719883440419UDI-DIDate13 Jun 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  • Withdrawn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
Lumbar Spine Orthosis
Model / Reference
E313
Primary DI / UDI-DI
04719883440419
Basic UDI-DI
471988344003HS
Direct Marketing DI
04719883440419
EMDN Code
Y060308 Lumbosacral spine orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000012336
Authorised representative
KOMAS Medical Technology GmbH DE-AR-000045617

Other devices from Fung Lead Medical & Sports Co., Ltd.

See all devices from Fung Lead Medical & Sports Co., 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