Skip to content

BIONIL MONOx

by Biosintex SRL Romania EUDAMED

Ref BX7044Model "Polyamide (tip 6.6) suture monofilament synthetic non-absorbable sterile surgical suture" EMDN H010201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05944756599133 Basic UDI-DIDate27 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
"Polyamide (tip 6.6) suture monofilament synthetic non-absorbable sterile surgical suture", BX7044
Primary DI / UDI-DI
05944756599133
Basic UDI-DI
B-05944756599133
EMDN Code
H010201010101 Polyamide monofilament with needle
Device Class
Class IIb
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 05944756599133|B-05944756599133 61 fields · synced 25 Oct 2026