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by TI Medical Private Limited 42 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2975-MED-2608201 Date23 Mar 2026IssuedStatusActive expires 22 Mar 2031

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  • Withdrawn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
08904248208124, 08904248207882, 08904248207714, 08904248207769, 08904248208360, 08904248208117, 08904248207912, 08904248208193, 08909296012587, 08904248208544, 08904248208650, 08904248232884, 08909296020766, 08904248208438, 08904248275058, 08904248290709, 08904248276031, 08904248208056, 08904248244160, 08904248273344, 08904248208100, 08904248273757, 08904248279858, 08904248266827, 08909296019234, 08904248208605, 08904248234352, 08909296021626, 08904248208742, 08904248207981, 08904248207790, 08904248207868, 08904248257597, 08904248274914, 08904248207707, 08904248268173, 08904248208063, 08904248223820, 08904248207837, 08904248208568, 08904248208292, 08909296019326, 08904248274945, 08909296012938, 08904248208087, 08904248208179, 08904248241558
Basic UDI-DI
89042482MAS005HX
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
Device Class
Class III
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

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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