BEUDAMED
    MDR MDR QMS Supplemented Expired

    HZ 1470094-1

    Manufacturer: Gebr. Brasseler GmbH & Co. KG
    Basic UDI-DIs
    0
    Scopes
    10
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    2
    Revision
    Rev. 4
    100
    Expired 100 days ago
    Expiry: February 28, 2026

    Basic Information

    Number
    HZ 1470094-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 23, 2024
    Expiry Date
    February 28, 2026 Expired
    Revision
    Rev. 4
    Manufacturer
    Gebr. Brasseler GmbH & Co. KG

    Certificate Lifecycle

    October 23, 2024 February 28, 2026

    Device Characteristics

    Sterile

    Scopes

    10 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER

    Quality Procedure Scope

    Device Group Class IIa Class I Sterile Reusable Surgical Instrument

    L159004 ENDODONTIC RASPS AND FILES, REUSABLE

    Quality Procedure Scope

    Device Group Class IIa

    Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLEUSE

    Quality Procedure Scope

    Device Group Class IIa

    Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLEUSE

    Quality Procedure Scope

    Device Group Class IIa

    V0199 CUTTING DEVICES, SINGLE-USE - OTHER

    Quality Procedure Scope

    Device Group Class IIa

    Q010399 SURGICAL DENTAL DEVICES – OTHER

    Quality Procedure Scope

    Device Group Class IIa

    P091305 BONE SAWS, SINGLE-USE

    Quality Procedure Scope

    Device Group Class IIa

    Q010102 ROOT CANAL FILLING DEVICES

    Quality Procedure Scope

    Device Group Class IIa Class I Sterile Reusable Surgical Instrument

    Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER

    Quality Procedure Scope

    Device Group Class IIa

    L2499 DERMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE – OTHER

    Preceding Certificates

    HZ 1470094-1 Supplemented
    Issued: March 14, 2024 Expires: February 28, 2026

    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.