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Monoshot™ HA

by Biovico Spółka z ograniczoną odpowiedzialnością

Ref Not applicable

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5902020847BVX5M Basic UDI-DI 05907381851007UDI-DIDate24 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

Poland
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Poland since 1 Sep 2026

Last checked 29 Oct 2026.

Specification

EUDAMED

Device Name
Biolevox™ HA
Model / Reference
Not applicable
Primary DI / UDI-DI
05907381851007
Basic UDI-DI
5902020847BVX5M
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