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Serafast®

by SERAG-WIESSNER GmbH & Co. KG 66 variants

Part of a family of 67 devices: see the family page

Ref 4O15321M

Serafast® (4O15321M) is a Class III device made by SERAG-WIESSNER GmbH & Co. KG, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 4044973CE21UB), 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 Number4044973CE21UB Basic UDI-DI 14044973127626UDI-DIDate6 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • D1453500024 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  • Withdrawn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
PGA-CL suture material
Model / reference
4O15321M
Primary DI / UDI-DI
14044973127626
Basic UDI-DI
4044973CE21UB
EMDN code
H010101010301 Poliglecaprone 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 POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE.

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)