Blog Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Blog Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

MD Atlas
Documents

Heater Cooler B.V.

Certificate 24M00085CRT01

Reissued

Valid until: Oct 6, 2029

Overview

Certificate number: 24M00085CRT01
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 191224M00085CRT01

Validity

Issued: Oct 6, 2024
Valid from: Oct 6, 2024
Valid until: Oct 6, 2029

Manufacturer

Manufacturer: Heater Cooler B.V.
Manufacturer SRN: NL-MF-000000246
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Supersedes

19M00153CRT01Quality management systemIssuedOct 6, 2021 → Oct 6, 2024

Scope coverage

Class IIb2

2 scopes

EMDN: Z120190 MDA 0303
Class IIb
Heater-Cooler unit
Class IIb

Documents

LanguagesEN