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AssuCryl®

by Assut Medical Sàrl 516 variants

Ref 4542Model Sterile synthetic absorbable surgical suture material

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07613406ACLPGA8T Basic UDI-DI Date23 Sep 2026RegisteredStatusActive

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

Coverage

1 jurisdiction

LithuaniaFranceRomania
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

  • France
  • Lithuania
  • Romania

Specification

EUDAMED

Device name
AssuCryl (PGA)
Model / reference
Sterile synthetic absorbable surgical suture material, 4542
Primary DI / UDI-DI
07613406009848, 07613406009831
Basic UDI-DI
07613406ACLPGA8T
EMDN code
H010101020101 Polyglycolic acid multifilament with needle for open surgery
Device class
Class III
EU registration type
Standard device
EU market of registration
Romania

Manufacturer details

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

Other devices from Assut Medical Sàrl

See all devices from Assut Medical Sàrl →

Properties

  • Supplied sterile
  • Implantable

Other properties (12)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No