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Mass

by TI Medical Private Limited 232 variants

Ref TI/C-BRO/01Model Monofilament Poly(p-dioxanone) Suture with needle (Violet), Monofilament Poly(p-dioxanone) Suture without needle (Violet)

Active European Union

CE MDR

Valid until

22 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier SZUTEST Konformitätsbewertungsstelle GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89042482MAS005HX Basic UDI-DI 08904248242968UDI-DIDate23 Mar 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2975-MED-2608201 Active

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    23 Mar 2026
    Expires
    22 Mar 2031
  • 2975-MED-2608201-D01 Active

    Technical documentation EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    23 Mar 2026
    Expires
    22 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Monofilament Poly(p-dioxanone) Suture
Model / reference
Monofilament Poly(p-dioxanone) Suture with needle (Violet), Monofilament Poly(p-dioxanone) Suture without needle (Violet), TI/C-BRO/01
Primary DI / UDI-DI
08904248242968
Basic UDI-DI
89042482MAS005HX
EMDN code
H010101010101 Polydioxanone monofilament with needle for open surgery
Device class
Class III
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000026561
Authorised representative
Obelis s.a. BE-AR-000000106

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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