Skip to content

AssuCryl® MonoSlow

by Assut Medical Sàrl 299 variants

Part of a family of 299 devices: see the family page

Ref MS4991Model Sterile synthetic absorbable surgical suture material

AssuCryl® MonoSlow (MS4991) is a Class III device made by Assut Medical Sàrl, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 07613406ACLMSPDOLC) with CE/MDR certificate 2262886TD01 valid until 1 Jan 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

1 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07613406ACLMSPDOLC Basic UDI-DI Date23 Sep 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2262886CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Aug 2025
    Expires
    1 Jan 2030
    Reason
    Ar data change
  • 2262886TD01 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Sep 2025
    Expires
    1 Jan 2030
    Reason
    Change approved

Timeline

5 dated events

  1. Certificate issued EUDAMED 2262886CE01
  2. Certificate issued EUDAMED 2262886TD01
  3. Registered EUDAMED 07613406ACLMSPDOLC
  4. Certificate expires EUDAMED 2262886TD01
  5. Certificate expires EUDAMED 2262886CE01

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
AssuCryl MonoSlow (PDO)
Model / reference
Sterile synthetic absorbable surgical suture material, MS4991
Primary DI / UDI-DI
07613406054404, 07613406054398
Basic UDI-DI
07613406ACLMSPDOLC
EMDN code
H010101010101 Polydioxanone monofilament with needle for open surgery
Device class
Class III
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CH-MF-000009358
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

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

Other devices from Assut Medical Sàrl

See all devices from Assut Medical Sàrl →

Properties

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