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Ceptre

by Healthium Medtech Limited 2 variants

Ref S33-2501-B-1

Ceptre (S33-2501-B-1) is a Class III device made by Healthium Medtech Limited, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI 8903837HML010WP), 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 Number8903837HML010WP Basic UDI-DI 08903837091437UDI-DIDate15 Oct 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-MDR/QS-043/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Jun 2026
    Expires
    22 Mar 2029
    Reason
    Add device or group
  • 2024-MDR/TD-043/A Active Supplemented

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Jun 2026
    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  • Withdrawn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
Knotted UHMWPE Suture PLDLA+β-TCP Wedge Anchor-2.5mm Single loaded suture-USP #2
Model / reference
S33-2501-B-1
Primary DI / UDI-DI
08903837091437
Basic UDI-DI
8903837HML010WP
Direct marketing DI
08903837091437
EMDN code
P09120102 Anchors, tendon and ligament synthesis
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 ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from Healthium Medtech Limited

See all devices from Healthium Medtech Limited →

Properties

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