Covidien llc

Certificat 10000481938-PA-NoMA-DNK

Rév. 7Modifié

Valide jusqu'au: 26 juin 2027

Le certificat 10000481938-PA-NoMA-DNK est un certificat Système de management de la qualité valide délivré à Covidien llc et enregistré dans EUDAMED. Valable jusqu'au 26 juin 2027. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: 10000481938-PA-NoMA-DNK
Type de certificat: Système de management de la qualité
Statut du certificat: Modifié
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 246010000481938-PA-NoMA-DNK7

Validité

Délivré le: 16 juil. 2026
Valide à partir du: 16 juil. 2026
Valide jusqu'au: 26 juin 2027

Fabricant

Fabricant: Covidien llc
SRN du fabricant: US-MF-000028763
Pays du fabricant: États-Unis

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

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: Non
Destination médicale: Non
RSCP applicable

Historique

Changements de statut

Modifié

Remplace

10000481938-PA-NoMA-DNKSystème de management de la qualitéDélivré8 juil. 2022 → 26 juin 2027

Périmètre de couverture

Classe IIa16Classe IIb4

20 périmètres

The Barrx™ Flex RFA Energy Generator is indicated for use for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, Barrett’s esophagus.
Classe IIb
The Barrx™ 90, Barrx™ Ultra Long, and Barrx™ 60 RFA Focal Catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to Barrett’s esophagus and esophageal squamous cell neoplasia, defined as moderate grade intra-epithelial neoplasia (MGIN), high-grade intraepithelial neoplasia (HGIN), and/or early squamous cell carcinoma (SCC) of the esophagus limited to the lamina propria (i.e. T1m2).
Classe IIb
Barrx™ Cleaning Cap
Classe IIa
ProdiGI™ Traction Wire
Classe IIa
ProdiGI Traction Magnet
Classe IIa
EndoflipTM 300 Pump System Endoflip TM 300 Display System
Classe IIa
Beacon Fine Needle Aspiration System
Classe IIa
SharkCore Fine Needle Biopsy System
Classe IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe
Classe IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe
Classe IIa
Barrx™ Flex RFA Energy Generator Barrx™ Flex RFA Energy Generator (model 1190A-230A)
Classe IIb
Barrx™ Ablation Catheters Barrx™ 60 RFA Focal Catheter (model 90-9300) Barrx™ 90 RFA Focal Catheter (model 90-9100) Barrx™ Ultra Long RFA Focal Catheter (model 90-9200) Barrx™ Channel RFA Endoscopic Catheter (TTS-1100) Barrx™ 360 Express RFA Balloon Catheter (model 64082)
Classe IIb
Barrx™ Cleaning caps Barrx™ RFA Cleaning Cap, small (model CP-001A) Barrx™ RFA Cleaning Cap, medium (model CP-002A)
Classe IIa
ProdiGI™ T raction Wire ERD-TW20, Primary Grasper with wire attached (20 mm) and a secondary grasper ERD-TW35, Primary grasper with wire attached (35 mm) and a secondary grasper ERD-TWSG, 2 Identical Secondary Graspers
Classe IIa
ProdiGITM Traction Magnet ERD-TMST, 2 identical graspers, 9.5mm length suture with magnet ERD-TMLG, 2 identical graspers, 17mm length suture with magnet
Classe IIa
EndoflipTM 300 Pump System EF-301 EndoflipTM 300 Display System EF-302
Classe IIa
DSN-19-01, Beacon EUS Delivery System with FNA Needle, 19-Gauge Nitinol DSN-22-01, Beacon EUS Delivery System with FNA Needle, 22-Gauge DSN-25-01, Beacon EUS Delivery System with FNA Needle, 25-Gauge N-19-05, Beacon FNA Needle, 19- Gauge NitinolN-22-05, Beacon FNA Needle, 22- Gauge Stainless Steel N-25-05, Beacon FNA Needle, 25- Gauge Stainless Steel SharkCore Fine Needle Biopsy
Classe IIa
DSL-19-01, Beacon EUS Delivery System with SharkCore FNB Needle, 19-Gauge Nitinol DSC-22-01, Beacon EUS Delivery System with SharkCore FNB Needle, 22-Gauge DSC-25-01, Beacon EUS Delivery System with SharkCore FNB Needle, 25-Gauge L-19-05, SharkCore FNB Needle, 19- Gauge Nitinol C-22-05, SharkCore FNB Needle, 22-Gauge Stainless Steel C-25-05, SharkCore FNB Needle, 25-Gauge Stainless Steel
Classe IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe EF-322N, EF-325N
Classe IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe ES-310, ES-320, ES-330
Classe IIa

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