E-SWIN SAS

Certificate HZ 1024982-1

Rev. 1Cancelled

Valid until: May 23, 2028

Certificate HZ 1024982-1, a Quality management system issued to E-SWIN SAS, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1024982-1
Certificate type: Quality management system
Certificate status: Cancelled
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1024982-11

Validity

Issued: Mar 2, 2025
Valid from: Mar 2, 2025
Valid until: May 23, 2028

Manufacturer

Manufacturer: E-SWIN SAS
Manufacturer SRN: FR-MF-000011807
Manufacturer country: France

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Cancelled

Supersedes

HZ 1024982-1Quality management systemIssuedMar 2, 2025 → May 23, 2028

Scope coverage

Class IIa1Class IIb1

2 scopes

Z120401 - GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS
Class IIa
Z129005 - GENERIC PHOTOSTIMULATORS
Class IIb

Documents

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