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Seralene®

by SERAG-WIESSNER GmbH & Co. KG 179 variants

Part of a family of 180 devices: see the family page

Ref LO404448

Seralene® (LO404448) is a Class III device made by SERAG-WIESSNER GmbH & Co. KG, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 4044973CE12UA), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

10 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier mdc medical device certification GmbH

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4044973CE12UA Basic UDI-DI 14044973108007UDI-DIDate20 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1453500025 Active

    Technical documentation EU MDR

    Certifier
    mdc medical device certification GmbH 0483
    Issued
    11 Aug 2026
    Expires
    10 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
PVDF Suture material
Model / reference
LO404448
Primary DI / UDI-DI
14044973108007
Basic UDI-DI
4044973CE12UA
EMDN code
H010201010601 Polyvinylidene fluoride and derivatives monofilament with needle
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006422

Similar devices in this category

Other devices filed under MONOFILAMENT NON-ABSORBABLE SYNTHETIC SUTURES.

Other devices from SERAG-WIESSNER GmbH & Co. KG

See all devices from SERAG-WIESSNER GmbH & Co. KG →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)