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MONO'x

by Biosintex SRL Romania EUDAMED

Ref BX928Model Poly(glycolide-co-caprolactone) (75/25) monofilament absorbable sterile surgical suture

EMDN H010101010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944756519223 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Poly(glycolide-co-caprolactone) (75/25) monofilament absorbable sterile surgical suture, BX928
Primary DI / UDI-DI
05944756519223
Basic UDI-DI
B-05944756519223
EMDN Code
H010101010301 Poliglecaprone and derivatives monofilament with needle
Device Class
Class III
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000001463

Other devices from Biosintex SRL

See all devices from Biosintex SRL →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 05944756519223|B-05944756519223 61 fields · synced 24 Oct 2026