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Heater Cooler B.V.

Netherlands NL-MF-000000246 Last updated 8 Jun 2026

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Devices
1
Registries
EUDAMED
FDA recalls
0

Catalogue1

  • hctronic Ref HCS-1

    Class IIb EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

Notified body 1912 2 certificates

  • 24M00085SUP01 Supplemented

    Quality management system EU MDR

    Issued
    23 Apr 2026
    Expires
    6 Oct 2029
    Reason
    Other
  • 19M00153CRT01 Expired

    Quality management system EU MDR

    Issued
    6 Oct 2021
    Expires
    6 Oct 2024

Related companies

Notified bodies

  • Notified body 1912

About

Consult with our experts? The HCTronic HCU concerns a new generation HCU for use during cardiac procedures in conjunction with a Heart-Lung Machine

From the manufacturer's own website. Source

Information

Country
Netherlands
Address
1, Koeweistraat, Waardenburg, Netherlands
Phone
+31651539010
PRRC contact
Martijn Emons
EUDAMED SRN
NL-MF-000000246