FUJIFILM Corporation

Certificat HZ 1194536-1

Rév. Rev.13Complété

Valide jusqu'au: 28 sept. 2026

Le certificat HZ 1194536-1 — un certificat Système de management de la qualité délivré à FUJIFILM Corporation — approche de son échéance. Valable jusqu'au 28 septembre 2026. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HZ 1194536-1
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: 3
Identifiant du certificat: 0197HZ 1194536-1Rev.13

Validité

Délivré le: 24 déc. 2025
Valide à partir du: 24 déc. 2025
Valide jusqu'au: 28 sept. 2026

Organisme notifié

Organisme notifié: TÜV Rheinland LGA Products GmbH
SRN de l'organisme notifié: 0197
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Oui
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

HZ 1194536-1Système de management de la qualitéComplété20 févr. 2025 → 28 sept. 2026

Périmètre de couverture

Classe IIa3Classe IIb2Classe I1

6 périmètres

Z110490 - VARIOUS ULTRASOUND INSTRUMENTS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Classe I
Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120204 - ACQUISITION AND MANAGEMENT INSTRUMENTS FOR ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120782 - GASTROENTEROLOGY INSTRUMENTS - SOFTWARE Z110311 - DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS
Classe IIa
Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES Z110302 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS MAMMOGRAPHY SYSTEMS
Classe IIb
Z110690 - VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS Z110402 - ULTRASOUND PROBES Z110401 - ULTRASOUND SCANNERS Z120290 - VARIOUS ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS Z110602 - DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS Z110501 - MAGNETIC RESONANCE (MR) SYSTEMS Z110490 - VARIOUS ULTRASOUND INSTRUMENTS
Classe IIa
Z110306 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS COMPUTED TOMOGRAPHS (CT) Z110307 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS REMOTE CONTROL TABLES Z11039012 - VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES X-RAY TUBE ASSEMBLY Z120792 - GASTROENTEROLOGICAL INSTRUMENTS GASTROENTEROLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE G030301 - POLYPECTOMY DEVICES POLYPECTOMY SNARES
Classe IIb
G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER R0799 - BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER
Classe IIa

Documents

LanguesEN

Périmètre de couverture

Classe IIa3Classe IIb2Classe I1

6 périmètres

Z110490 - VARIOUS ULTRASOUND INSTRUMENTS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Classe I
Z120206 - LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120204 - ACQUISITION AND MANAGEMENT INSTRUMENTS FOR ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120782 - GASTROENTEROLOGY INSTRUMENTS - SOFTWARE Z110311 - DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS
Classe IIa
Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES Z110302 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS MAMMOGRAPHY SYSTEMS
Classe IIb
Z110690 - VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS Z110402 - ULTRASOUND PROBES Z110401 - ULTRASOUND SCANNERS Z120290 - VARIOUS ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY INSTRUMENTS Z120210 - ENT ENDOSCOPY INSTRUMENTS Z110602 - DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS Z110501 - MAGNETIC RESONANCE (MR) SYSTEMS Z110490 - VARIOUS ULTRASOUND INSTRUMENTS
Classe IIa
Z110306 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS COMPUTED TOMOGRAPHS (CT) Z110307 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS REMOTE CONTROL TABLES Z11039012 - VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES X-RAY TUBE ASSEMBLY Z120792 - GASTROENTEROLOGICAL INSTRUMENTS GASTROENTEROLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE G030301 - POLYPECTOMY DEVICES POLYPECTOMY SNARES
Classe IIb
G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER R0799 - BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER
Classe IIa

Certificat HZ 1194536-1

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat HZ 1194536-1

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant