smartQare BV

Certificate 22M00055CRT01

Issued

Valid until: Aug 24, 2027

Certificate 22M00055CRT01 is a valid Quality management system issued to smartQare BV and registered in EUDAMED. Valid until August 24, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 22M00055CRT01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 191222M00055CRT01

Validity

Issued: Aug 24, 2022
Valid from: Aug 24, 2022
Valid until: Aug 24, 2027

Manufacturer

Manufacturer: smartQare BV
Manufacturer SRN: NL-MF-000003491
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: Yes
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: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0203
Class IIa
viQtor
Class IIa

Documents

LanguagesEN