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Astralen/Polyester

by Assut Medical Sàrl 305 variants

Ref 33868Model Sterile synthetic non-absorbable surgical suture material

Active European Union

CE MDD

Valid until

Not listed

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

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/MDD NumberB-07613406014408 Basic UDI-DI Date7 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
Sterile synthetic non-absorbable surgical suture material, 33868
Primary DI / UDI-DI
07613406014408, 07613406014392
Basic UDI-DI
B-07613406014408, B-07613406014392
EMDN code
H010201020201 Polyester multifilament with needle for open surgery
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

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