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Hyprojoint

by Bloomage Biotechnology Corp., Ltd.

Ref /Model 2.5ml

Active European Union

CE MDR

Valid until

31 Jan 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

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 Number69480604HX0006J7 Basic UDI-DI 06948060430167UDI-DIDate8 Apr 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/TD-004 Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    31 Jan 2024
    Expires
    31 Jan 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
2.5ml, /
Primary DI / UDI-DI
06948060430167
Basic UDI-DI
69480604HX0006J7
Direct Marketing DI
06948060430167
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000013641
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Bloomage Biotechnology Corp., Ltd.

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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