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Biolevox™ HA tendon

by Biovico Spółka z ograniczoną odpowiedzialnością

Ref PRO00797

Active European Union

CE MDR

Valid until

15 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

The Biolevox HA tendon device is a Class III surgical implant used in orthopedic surgery to treat certain types of tendinosis. This device features a unique suturing mechanism and is designed for minimally invasive procedures.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5902020847BVXTZT Basic UDI-DI 05907381850925UDI-DIDate21 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
PRO00797
Primary DI / UDI-DI
05907381850925
Basic UDI-DI
5902020847BVXTZT
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000010559

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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