Drägerwerk AG & Co. KGaA

Certificat G10 010578 0039

Rév. Rev. 15Complété

Valide jusqu'au: 17 mars 2030

Le certificat G10 010578 0039 est un certificat Système de management de la qualité valide délivré à Drägerwerk AG & Co. KGaA et enregistré dans EUDAMED. Valable jusqu'au 17 mars 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: G10 010578 0039
Type de certificat: Système de management de la qualité
Statut du certificat: Complété
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 0123G10 010578 0039Rev. 15

Validité

Délivré le: 18 juin 2026
Valide à partir du: 18 juin 2026
Valide jusqu'au: 17 mars 2030

Organisme notifié

Organisme notifié: TÜV SÜD Product Service GmbH
SRN de l'organisme notifié: 0123
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Non
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: Non
Enregistrement initial: Non
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Oui
Destination médicale: Non
RSCP applicable: Non
Conditions applicables: Non
MOS hors EUDAMED: Non
Type SMQ/MOS: Classe IIb uniquement

Historique

Changements de statut

Complété

Remplace

G10 010578 0039Système de management de la qualitéDélivré3 févr. 2025 → 17 mars 2030

Périmètre de couverture

Classe IIb9Classe IIa6

15 périmètres

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; -
Classe IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; -
Classe IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS; -
Classe IIa
A060304 - INTRA-OPERATION FLUID COLLECTION DEVICES; -
Classe 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
Classe IIb
Z120804 - NEONATOLOGY INSTRUMENTS; Warming therapy devices intended to provide controlled ambient conditions for premature babies and neonates in closed and open care therapy
Classe IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS; Devices for the purpose of ventilation and/or anesthesia
Classe 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
Classe IIb
R020107 - THERMOREGULATED BREATHING CIRCUITS ; Inspiratory (and expiratory) heated disposable breathing circuit for conducting humidified breathing gas from humidifier to patient
Classe IIb
R020101 - STANDARD BREATHING CIRCUITS; Devices intended to administer gases for the purpose of ventilation
Classe IIb
Z120401 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS; Devices intended to provide clinical data on the network to support diagnosis and therapy decisions
Classe 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
Classe IIb
Z121590 - VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS; -
Classe IIa
Z120390 - VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS; -
Classe IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS
Classe IIb

Documents

LanguesEN

Périmètre de couverture

Classe IIb9Classe IIa6

15 périmètres

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; -
Classe IIa
Z12040192 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE; -
Classe IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS; -
Classe IIa
A060304 - INTRA-OPERATION FLUID COLLECTION DEVICES; -
Classe 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
Classe IIb
Z120804 - NEONATOLOGY INSTRUMENTS; Warming therapy devices intended to provide controlled ambient conditions for premature babies and neonates in closed and open care therapy
Classe IIb
Z120301 - ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS; Devices for the purpose of ventilation and/or anesthesia
Classe 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
Classe IIb
R020107 - THERMOREGULATED BREATHING CIRCUITS ; Inspiratory (and expiratory) heated disposable breathing circuit for conducting humidified breathing gas from humidifier to patient
Classe IIb
R020101 - STANDARD BREATHING CIRCUITS; Devices intended to administer gases for the purpose of ventilation
Classe IIb
Z120401 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS; Devices intended to provide clinical data on the network to support diagnosis and therapy decisions
Classe 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
Classe IIb
Z121590 - VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS; -
Classe IIa
Z120390 - VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS; -
Classe IIa
Z120302 - VITAL SIGNS MONITORING INSTRUMENTS
Classe IIb

Certificat G10 010578 0039

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat G10 010578 0039

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant