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Filaxyn™ Polydioxanone Suture

by Meril Endo Surgery Pvt. Ltd. 149 variants

Ref ME/BRC/007

Active European Union

CE MDR

Valid until

15 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 105557 0010 Date30 Jun 2026IssuedStatusActive expires 15 Jan 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

Bulgaria
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Bulgaria since 8 Feb 2016

Last checked 23 Oct 2026.

Specification

EUDAMED

Device Name
Filaxyn™/Aspiron™ Absorbable Poly (P-Dioxanone) Surgical Suture
Model / Reference
ME/BRC/007
Primary DI / UDI-DI
18904255205670, 18904255204468, 18906070907319, 18904255216065, 18906070904356, 18906070908842, 18904255222981, 18906070904349, 18906070904325, 18906070901119, 18904255221601, 18904255200422, 18904255208404, 18904255207674, 18906070904370, 18904255230962, 18906070904424, 18904255230375, 18906070902031, 18904255230788, 18906070904332, 18906070901836, 18906070901805, 18904255249988, 18904255221397, 18904255221502, 18904255221564, 18904255221533, 18904255221496, 18904255201788, 18906070908736, 18904255231990, 18904255230344, 18904255221380, 18904255230917, 18904255207698, 18904255216096, 18906070904448, 18904255201627, 18904255204413, 18904255204635, 18906070904431, 18904255211084, 18904255229317, 18904255235394, 18904255230795, 18904255207681, 18904255202921, 18904255221571, 18906070907302
Basic UDI-DI
89042552MES_PDX04XX
EMDN Code
H010101010101, H010101010103
Device Class
Class III
EU market of registration
Bulgaria
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000010999
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Meril Endo Surgery Pvt. Ltd.

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No