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MD Atlas
Documents

Heater Cooler B.V.

Certificate 19M00153CRT01

Issued

Valid until: Oct 6, 2024

Certificate 19M00153CRT01, a Quality management system issued to Heater Cooler B.V., has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: 19M00153CRT01
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 191219M00153CRT01

Validity

Issued: Oct 6, 2021
Valid from: Oct 6, 2021
Valid until: Oct 6, 2024

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

MDA 0303
Class IIb
Heater-Cooler unit
Class IIb

Documents

LanguagesEN

Manufacturer

Manufacturer: Heater Cooler B.V.
Manufacturer SRN: NL-MF-000000246
Manufacturer country: Netherlands