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

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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

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