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by Guangzhou New design Biotechnology Co., Ltd. China EUDAMED

Ref X2Model TJ-608

EMDN Y061299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697570507TJ-608H7 Basic UDI-DIDate14 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Bunion Corrector
Model / Reference
TJ-608, X2
Primary DI / UDI-DI
06975705070129
Basic UDI-DI
697570507TJ-608H7
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028399
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Guangzhou New design Biotechnology Co., Ltd.

See all devices from Guangzhou New design Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 85d1479c-fa2c-4261-b7fc-482163d49dad 61 fields · synced 24 Oct 2026