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DemeLENE

by DemeTECH Corp United States EUDAMED

Ref PM196011F12P

EMDN H010201010401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10652927819271 Basic UDI-DIDate13 Jul 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
PM196011F12P
Primary DI / UDI-DI
10652927819271
Basic UDI-DI
B-10652927819271
EMDN Code
H010201010401 Polypropylene monofilament with needle for open surgery
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000026972
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

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 10652927819271|B-10652927819271 61 fields · synced 24 Oct 2026