Covidien llc

Certificate 10000481938-PA-NoMA-DNK

Rev. 6Issued

Valid until: Jun 26, 2027

Certificate 10000481938-PA-NoMA-DNK is a valid Quality management system issued to Covidien llc and registered in EUDAMED. Valid until June 26, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000481938-PA-NoMA-DNK
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000481938-PA-NoMA-DNK6

Validity

Issued: Jul 8, 2022
Valid from: Jul 8, 2022
Valid until: Jun 26, 2027

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
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: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa16Class IIb4

20 scopes

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.
Class 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).
Class IIb
Barrx™ Cleaning Cap
Class IIa
ProdiGI™ Traction Wire
Class IIa
ProdiGI Traction Magnet
Class IIa
EndoflipTM 300 Pump System Endoflip TM 300 Display System
Class IIa
Beacon Fine Needle Aspiration System
Class IIa
SharkCore Fine Needle Biopsy System
Class IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe
Class IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe
Class IIa
Barrx™ Flex RFA Energy Generator Barrx™ Flex RFA Energy Generator (model 1190A-230A)
Class 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)
Class IIb
Barrx™ Cleaning caps Barrx™ RFA Cleaning Cap, small (model CP-001A) Barrx™ RFA Cleaning Cap, medium (model CP-002A)
Class 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
Class 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
Class IIa
EndoflipTM 300 Pump System EF-301 EndoflipTM 300 Display System EF-302
Class 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
Class 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
Class IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe EF-322N, EF-325N
Class IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe ES-310, ES-320, ES-330
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa16Class IIb4

20 scopes

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.
Class 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).
Class IIb
Barrx™ Cleaning Cap
Class IIa
ProdiGI™ Traction Wire
Class IIa
ProdiGI Traction Magnet
Class IIa
EndoflipTM 300 Pump System Endoflip TM 300 Display System
Class IIa
Beacon Fine Needle Aspiration System
Class IIa
SharkCore Fine Needle Biopsy System
Class IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe
Class IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe
Class IIa
Barrx™ Flex RFA Energy Generator Barrx™ Flex RFA Energy Generator (model 1190A-230A)
Class 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)
Class IIb
Barrx™ Cleaning caps Barrx™ RFA Cleaning Cap, small (model CP-001A) Barrx™ RFA Cleaning Cap, medium (model CP-002A)
Class 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
Class 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
Class IIa
EndoflipTM 300 Pump System EF-301 EndoflipTM 300 Display System EF-302
Class 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
Class 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
Class IIa
Endoflip TM Endolumenal Functional Lumen Imaging Probe EF-322N, EF-325N
Class IIa
Esoflip TM Endolumenal Functional Lumen Imaging Probe ES-310, ES-320, ES-330
Class IIa

Certificate 10000481938-PA-NoMA-DNK

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate 10000481938-PA-NoMA-DNK

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer