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Trusteel

by Healthium Medtech Limited 2 variants

Ref TS654P6

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8903837H01020201012B Basic UDI-DI 08903837069962UDI-DIDate23 Sep 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-014/C Expiring Supplemented Expires in 289 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Jul 2025
    Expires
    15 Aug 2027
    Reason
    Other
  • 2022-MDR/TD-014/C Expiring Supplemented Expires in 289 days

    Technical documentation EU MDR

    Certifier
    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  • Withdrawn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
Monofilament 316 Lvm Stainless Steel Sterile Non-Absorbable Surgical Suture
Model / Reference
TS654P6
Primary DI / UDI-DI
08903837069962
Basic UDI-DI
8903837H01020201012B
EMDN Code
H010202010101 Stainless steel monofilament with needle
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

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Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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