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Monoglyde

by Healthium Medtech Limited 2 variants

Ref 11H75DY30-12

Monoglyde (11H75DY30-12) is a Class III device made by Healthium Medtech Limited, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 8903837H0101010103ZG) with CE/MDR certificate 2022-MDR/QS-008/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 Number8903837H0101010103ZG Basic UDI-DI 08903837820563UDI-DIDate23 Sep 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2022-MDR/QS-008/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-008/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-008/C
  2. Certificate issued EUDAMED 2022-MDR/TD-008/C
  3. Registered EUDAMED 8903837H0101010103ZG
  4. Certificate expires EUDAMED 2022-MDR/QS-008/C
  5. Certificate expires EUDAMED 2022-MDR/TD-008/C

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device name
Monofilament Poliglecaprone 25 Sterile Synthetic Absorbable Surgical Suture
Model / reference
11H75DY30-12
Primary DI / UDI-DI
08903837820563
Basic UDI-DI
8903837H0101010103ZG
EMDN code
H010101010301 Poliglecaprone and derivatives monofilament with needle
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 POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE.

Other devices from Healthium Medtech Limited

See all devices from Healthium Medtech Limited →

Properties

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