Drägerwerk AG & Co. KGaA

Certificate G10 010578 0039

Rev. Rev. 15Supplemented

Valid until: Mar 17, 2030

Certificate G10 010578 0039 is a valid Quality management system issued to Drägerwerk AG & Co. KGaA and registered in EUDAMED. Valid until March 17, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 010578 0039
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0123G10 010578 0039Rev. 15

Validity

Issued: Jun 18, 2026
Valid from: Jun 18, 2026
Valid until: Mar 17, 2030

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

G10 010578 0039Quality management systemIssuedFeb 3, 2025 → Mar 17, 2030

Scope coverage

Class IIb9Class IIa6

15 scopes

Z120309 - MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES;Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS;R0402 - NATURAL BREATHING FILTERS;R0401 - VENTILATION FILTERS;R030201 - VENTILATION BALLOONS;R0301 - RESPIRATORY MASKS;R02 - BREATHING CIRCUITS AND CATHETER MOUNTS; -
Class IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; -
Class IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS; -
Class IIa
A060304 - INTRA-OPERATION FLUID COLLECTION DEVICES; -
Class IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; Software intended to provide clinical information for the purpose of supporting patient management and the decision making process
Class IIb
Z120804 - NEONATOLOGY INSTRUMENTS; Warming therapy devices intended to provide controlled ambient conditions for premature babies and neonates in closed and open care therapy
Class IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS; Devices for the purpose of ventilation and/or anesthesia
Class IIb
Z120309 - MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES; Devices intended to distribute or supply gases, vacuum, electricity or data to equipment in diagnostic, therapy or surgery
Class IIb
R020107 - THERMOREGULATED BREATHING CIRCUITS ; Inspiratory (and expiratory) heated disposable breathing circuit for conducting humidified breathing gas from humidifier to patient
Class IIb
R020101 - STANDARD BREATHING CIRCUITS; Devices intended to administer gases for the purpose of ventilation
Class IIb
Z120401 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS; Devices intended to provide clinical data on the network to support diagnosis and therapy decisions
Class IIb
Z1203019092 - VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - MEDICAL DEVICE SOFTWARE; Software intended to support the decision making process in anesthesia and/or intensive care
Class IIb
Z121590 - VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS; -
Class IIa
Z120390 - VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS; -
Class IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIb9Class IIa6

15 scopes

Z120309 - MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES;Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS;R0402 - NATURAL BREATHING FILTERS;R0401 - VENTILATION FILTERS;R030201 - VENTILATION BALLOONS;R0301 - RESPIRATORY MASKS;R02 - BREATHING CIRCUITS AND CATHETER MOUNTS; -
Class IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; -
Class IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS; -
Class IIa
A060304 - INTRA-OPERATION FLUID COLLECTION DEVICES; -
Class IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; Software intended to provide clinical information for the purpose of supporting patient management and the decision making process
Class IIb
Z120804 - NEONATOLOGY INSTRUMENTS; Warming therapy devices intended to provide controlled ambient conditions for premature babies and neonates in closed and open care therapy
Class IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS; Devices for the purpose of ventilation and/or anesthesia
Class IIb
Z120309 - MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES; Devices intended to distribute or supply gases, vacuum, electricity or data to equipment in diagnostic, therapy or surgery
Class IIb
R020107 - THERMOREGULATED BREATHING CIRCUITS ; Inspiratory (and expiratory) heated disposable breathing circuit for conducting humidified breathing gas from humidifier to patient
Class IIb
R020101 - STANDARD BREATHING CIRCUITS; Devices intended to administer gases for the purpose of ventilation
Class IIb
Z120401 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS; Devices intended to provide clinical data on the network to support diagnosis and therapy decisions
Class IIb
Z1203019092 - VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - MEDICAL DEVICE SOFTWARE; Software intended to support the decision making process in anesthesia and/or intensive care
Class IIb
Z121590 - VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS; -
Class IIa
Z120390 - VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS; -
Class IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS
Class IIb

Certificate G10 010578 0039

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate G10 010578 0039

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer