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Trugldye

by Healthium Medtech Limited 2 variants

Ref 2H75DY26-12

Expiring European Union

CE MDR

Valid until

15 Aug 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

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 Number8903837H0101010201ZH Basic UDI-DIDate23 Sep 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-005/C Expiring Supplemented Expires in 290 days

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    10 Jul 2025
    Expires
    15 Aug 2027
    Reason
    Other
  • 2022-MDR/TD-005/C Expiring Supplemented Expires in 290 days

    Technical documentation EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    10 Jul 2025
    Expires
    15 Aug 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Braided and Coated Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture
Model / Reference
2H75DY26-12
Primary DI / UDI-DI
08903837820662
Basic UDI-DI
8903837H0101010201ZH
EMDN Code
H010101020101 Polyglycolic acid multifilament with needle for open surgery
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000008421
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Other devices from Healthium Medtech Limited

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  • Sironix

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  • Clinifibre

    Class IIb

  • Trusynth Fast

    Class III

  • Trugldye

    Class III

  • Trusilk

    Class III

See all devices from Healthium Medtech Limited →

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