The Surgical Company International B.V.

Certificate 2259019CE03

Rev. 1Amended

Valid until: Jun 10, 2027

Certificate 2259019CE03 is a valid Quality management system issued to The Surgical Company International B.V. and registered in EUDAMED. Valid until June 10, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2259019CE03
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03442259019CE031

Validity

Issued: Apr 2, 2025
Valid from: Apr 2, 2025
Valid until: Jun 10, 2027

Manufacturer

Manufacturer: The Surgical Company International B.V.
Manufacturer SRN: NL-MF-000001973
Manufacturer country: Netherlands

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Mistral-Air® Surgical Access Plus SterileClass I
8719867EMDNT030301S6T

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

2259019CE03IssuedFeb 24, 2025 → Jun 10, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I1

1 scope

DEVICE
Class I

Documents

LanguagesEN