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Trulene

by Healthium Medtech Limited 2 variants

Ref 8G70DZ17DA-12

Trulene (8G70DZ17DA-12) is a Class III device made by Healthium Medtech Limited, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 8903837H010201010426) with CE/MDR certificate 2022-MDR/QS-011/C valid until 15 Aug 2027, active as of 24 Oct 2026.

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8903837H010201010426 Basic UDI-DI 08903837820747UDI-DIDate23 Sep 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-011/C Expiring Supplemented Expires in 276 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-011/C Expiring Supplemented Expires in 276 days

    Technical documentation EU MDR

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

Timeline

5 dated events

  1. Certificate issued EUDAMED 2022-MDR/QS-011/C
  2. Certificate issued EUDAMED 2022-MDR/TD-011/C
  3. Registered EUDAMED 8903837H010201010426
  4. Certificate expires EUDAMED 2022-MDR/QS-011/C
  5. Certificate expires EUDAMED 2022-MDR/TD-011/C

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device name
Monofilament Polypropylene Sterile Non-Absorbable Surgical Suture
Model / reference
8G70DZ17DA-12
Primary DI / UDI-DI
08903837820747
Basic UDI-DI
8903837H010201010426
EMDN code
H010201010401 Polypropylene 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-000008421
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Similar devices in this category

Other devices filed under POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Healthium Medtech Limited

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Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)