BEUDAMED
    MDR MDR QMS Issued

    HZ 2068842-1

    Manufacturer: Osteopore International Pte Ltd
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0
    672
    Valid for 672 days
    Expiry: April 11, 2028

    Basic Information

    Number
    HZ 2068842-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    April 12, 2023
    Expiry Date
    April 11, 2028
    Revision
    Rev.0
    Manufacturer
    Osteopore International Pte Ltd

    Certificate Lifecycle

    April 12, 2023 April 11, 2028

    Device Characteristics

    Sterile

    Scopes

    Quality Procedure Scope

    Device Group Class III

    P900402 - STRUCTURES FILLING, REPLACEMENT AND RECONSTRUCTION DEVICES RESORBABLE FILLING AND RECONSTRUCTION DEVICES Intended purpose: Bioresorbable Implants for use in the repair of neurosurgical burr holes and fresh craniotomy cuts. It is also used in the augmentation or restoration of bony contour in the craniofacial skeleton.

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.