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DemeLENE

by DemeTECH Corp 55 variants

Ref PM19600,8D12M

DemeLENE (PM19600,8D12M) is a Class IIb device made by DemeTECH Corp, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI B-10652927803690), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10652927803690 Basic UDI-DI 10652927803690UDI-DIDate13 Jul 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
PM19600, 8D12M
Primary DI / UDI-DI
10652927803690
Basic UDI-DI
B-10652927803690
EMDN code
H010201010401 Polypropylene monofilament with needle for open surgery
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

Manufacturer details

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

Similar devices in this category

Other devices filed under POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

  • Supplied sterile
  • Implantable
Other properties (10, all answered No)