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Helysis

by Healthium Medtech Limited 2 variants

Ref S23-6020-B

Helysis (S23-6020-B) is a Class III device made by Healthium Medtech Limited, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI 8903837HML006WY), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

22 Mar 2029

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8903837HML006WY Basic UDI-DI 08903837092144UDI-DIDate15 Oct 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-MDR/QS-042/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    28 Nov 2025
    Expires
    22 Mar 2029
    Reason
    Add device or group
  • 2024-MDR/TD-042/A Active Supplemented

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    28 Nov 2025
    Expires
    22 Mar 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
PLDLA+β-TCP Interference Screw 6mm x 20mm
Model / reference
S23-6020-B
Primary DI / UDI-DI
08903837092144
Basic UDI-DI
8903837HML006WY
Direct marketing DI
08903837092144
EMDN code
P09120605 Interference screws
Device class
Class III
EU registration type
Standard device
EU market of registration
Italy

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 INTERFERENCE SCREWS.

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Properties

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