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FreeZ knee brace

by e-life International Co., Ltd.

Ref SKNFZ60 (Universal/UNI/BK)Model Knee Brace Series

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 Number471230298KNR4 Basic UDI-DI 04719961401646UDI-DIDate30 Apr 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  • Withdrawn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
Knee orthosis and tubular support bandage
Model / reference
Knee Brace Series, SKNFZ60 (Universal/UNI/BK)
Primary DI / UDI-DI
04719961401646
Basic UDI-DI
471230298KNR4
EMDN code
Y061209 Knee orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000009901
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from e-life International Co., Ltd.

See all devices from e-life International Co., Ltd. →

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