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Lower Limb Brace

by Shijiazhuang Mailaike Medical Devices Co., Ltd

Ref Hinge Knee Support:HK001Model Hinge Knee Support：HK001,HK002,HK003,HK004,HK005,HK006,HK007,HK008,HK009,HK010,HK011,HK012,HK013 Knee Support： KN001,KN002,KN003,KN004,KN005,KN006,KN007,KN008,KN009,KN010,KS001,KS002,KS003, etc.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697839742LLBZ5 Basic UDI-DI 06978397425000UDI-DIDate4 Sep 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  • Withdrawn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
Lower Limb Brace
Model / Reference
Hinge Knee Support：HK001, HK002, HK003, HK004, HK005, HK006, HK007, HK008, HK009, HK010, HK011, HK012, HK013 Knee Support： KN001, KN002, KN003, KN004, KN005, KN006, KN007, KN008, KN009, KN010, KS001, KS002, KS003, etc., Hinge Knee Support:HK001
Primary DI / UDI-DI
06978397425000
Basic UDI-DI
697839742LLBZ5
EMDN Code
Y090618 Leg and knee protections (including socks for amputated legs)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shijiazhuang Mailaike Medical Devices 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