Atos Medical AB

Certificate C520850

Rev. 3Issued

Valid until: Feb 11, 2030

Certificate C520850 is a valid Quality management system issued to Atos Medical AB and registered in EUDAMED. Valid until February 11, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C520850
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5208503

Validity

Issued: Feb 12, 2025
Valid from: Feb 12, 2025
Valid until: Feb 11, 2030

Manufacturer

Manufacturer: Atos Medical AB
Manufacturer SRN: SE-MF-000000725
Manufacturer country: Sweden

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

: Yes
: No
: No
: No
: Yes
: No
: No
: Yes
: Yes
: No
: No
: No

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa12Class IIb10Class I2

24 scopes

Sterile single-use dressing
Class I
TrachPhone is a single use Heat and Moisture Exchanger (HME) which is intended for pulmonary rehabilitation in patients selfventilating through a tracheostoma.
Class IIa
Provox Life Oxygen is a single-use accessory to Provox Life HMEs. It allows additional oxygen supply for patients breathing through a tracheostoma using Provox Life HMEs.
Class IIa
Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. The Provox Insertion System is a sterile single use device intended for anterograde replacement of the Provox Vega voice prosthesis. This replacement procedure is carried out by a medical professional in accordance with local
Class IIb
Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. The Provox Insertion System is a sterile single use device intended for anterograde replacement of the Provox Vega voice prosthesis. This replacement procedure is carried out by a medical professional in accordance with local
Class IIb
Provox XtraFlange is a silicone washer intended to reduce periprosthetic leakage that is detected on patients using indwelling Provox voice prostheses. Placement is performed by a medical doctor or a trained medical professional in accordance with local or national guidelines.
Class IIb
The Provox2 Voice Rehabilitation System is intended for use in surgical, prosthetic voice restoration after total laryngectomy. The prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis.
Class IIb
The Provox NiD voice rehabilitation system is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision. The Provox NiD is intended for single patient use.
Class IIb
The Provox GuideWire is a sterile single use insertion device intended for placement of a sterile Provox indwelling Voice Prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling Voice Prosthesis.
Class IIa
Provox Plug is intended to seal the inner lumen of Provox2 voice prosthesis and Provox ActiValve and therefore stop leakageof both air and fluids through the voice prosthesis. Provox Vega Plug is intended to seal the inner lumen of Provox Vega voice prosthesis and therefore stop leakage of both air and fluids through the voice prosthesis.
Class IIa
The Provox Dilator is intended to dilate or stent the tracheoesophageal puncture in laryngectomized patients.
Class IIa
The Provox Dilator 17 and 20 is intended to dilate or stent the tracheoesophageal puncture in laryngectomized patients.
Class IIa
Freevent Dressing Softfoam
Class I
TrachPhone
Class IIa
Provox Life Oxygen
Class IIa
Provox Vega
Class IIb
Provox Vega XtraSeal
Class IIb
Provox XtraFlange
Class IIb
Provox2 Voice Prosthesis
Class IIb
Provox NID
Class IIb

1 / 2

Documents

LanguagesEN