Medartis AG

Certificate HZ 1809678-1

Rev. Rev. 2Supplemented

Valid until: Dec 29, 2026

Certificate HZ 1809678-1 is a valid Quality management system issued to Medartis AG and registered in EUDAMED. Valid until December 29, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1809678-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1809678-1Rev. 2

Validity

Issued: Nov 4, 2024
Valid from: Nov 4, 2024
Valid until: Dec 29, 2026

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1809678-1Quality management systemIssuedJun 28, 2023 → Dec 29, 2026

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

L091099 - Osteosynthesis Instruments, reusable - other L9099 - Surgical Instruments, reusable - other
Class I
L091001 - Instruments for Insertion and Extraction of Materials for Osteosynthesis, reusable Q010403 - Orthodontic Brackets and Buttons V9012 - Non-Specialist Surgical Instruments and Kits, single-use Z121305 - Motorised Orthopaedic Surgery System Instruments Z121390 - Various Orthopaedic and Traumatology Instruments
Class IIa
Osteosynthesis Devices, Devices for Tendon and and Ligament Synthesis P091201 - Osteosynthesis Staples and Anchors P091205 - Bone Fixation Plates P091206 - Bone Fixation Screws, Tendon and Ligament Synthesis Screws Software, CMX Portal V92 - Not Otherwise Classified Devices – Others
Class IIb

Documents

LanguagesEN

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

L091099 - Osteosynthesis Instruments, reusable - other L9099 - Surgical Instruments, reusable - other
Class I
L091001 - Instruments for Insertion and Extraction of Materials for Osteosynthesis, reusable Q010403 - Orthodontic Brackets and Buttons V9012 - Non-Specialist Surgical Instruments and Kits, single-use Z121305 - Motorised Orthopaedic Surgery System Instruments Z121390 - Various Orthopaedic and Traumatology Instruments
Class IIa
Osteosynthesis Devices, Devices for Tendon and and Ligament Synthesis P091201 - Osteosynthesis Staples and Anchors P091205 - Bone Fixation Plates P091206 - Bone Fixation Screws, Tendon and Ligament Synthesis Screws Software, CMX Portal V92 - Not Otherwise Classified Devices – Others
Class IIb

Certificate HZ 1809678-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 1809678-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer