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

Fabricant

Fabricant: Drägerwerk AG & Co. KGaA
SRN du fabricant: DE-MF-000005329
Pays du fabricant: Allemagne

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 0123
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

: Non
: Non
: Non
: Non
: Non
: Non
: Non
: Oui
: Oui
: Non
: Non
: Non

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

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