Nemo Healthcare B.V.

Certificate 23M00032CRT01

Rev. 23M00032CRT02Amended

Valid until: Sep 28, 2028

Certificate 23M00032CRT01 is a valid Quality management system issued to Nemo Healthcare B.V. and registered in EUDAMED. Valid until September 28, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 23M00032CRT01
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 191223M00032CRT0123M00032CRT02

Validity

Issued: Sep 28, 2023
Valid from: Sep 28, 2023
Valid until: Sep 28, 2028

Manufacturer

Manufacturer: Nemo Healthcare B.V.
Manufacturer SRN: NL-MF-000002979
Manufacturer country: Netherlands

Notified body

Notified body: Kiwa Assurance B.V.
Notified body SRN: 1912
Notified body country: Netherlands

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: No
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

23M00032CRT01Quality management systemIssuedSep 28, 2023 → Sep 28, 2028

Scope coverage

Class IIb3

3 scopes

MDA 0203
Class IIb
Nemo Fetal Monitoring System (NFMS)
Class IIb
NemoRemote
Class IIb

Documents

LanguagesEN