Systolé Hardware B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000006605
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Systolé Hardware B.V. makes
Systolé Hardware B.V. manufactures the Multichannel ECG Recorder H4, a device designed for recording multiple ECG channels to monitor cardiac activity in clinical or field settings.
The Multichannel ECG Recorder H4 is classified as a Class IIa medical device and is registered in the EU’s eudamed database. The company is based in the Netherlands.
Catalogue
Multichannel ECG Recorder H4 Ref Multichannel Holter ECG Recorder H4
CE MDD EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000006605
- EUDAMED status
- Active
- EUDAMED registered name
- Systolé Hardware B.V.
- EUDAMED abbreviated name
- Systolé Hardware
- Registered address
- 179, Herikerbergweg 179, 1101 CN, Amsterdam, Netherlands
- [email protected]
- Phone
- +31 88 045 06 00
- PRRC contact
- NA NA
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1147806-1 Cancelled
Quality management system EU MDR
- Issued
- 30 Apr 2025
- Expires
- 29 Apr 2030
- Reason
- Other
Frequently asked questions
How many devices does Systolé Hardware B.V. have in the registry?
The registry currently lists 1 device for Systolé Hardware B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Systolé Hardware B.V.'s devices?
Among its 1 most recently registered device, Systolé Hardware B.V. has devices listed in EUDAMED (1 device).
What risk classes do Systolé Hardware B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Systolé Hardware B.V.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Systolé Hardware B.V.?
EUDAMED lists 1 certificate for Systolé Hardware B.V. (quality management system) under MDR. The most recent was issued on 2025-04-30.
What are the newest devices from Systolé Hardware B.V. in the registry?
The most recently registered devices listed for Systolé Hardware B.V. include Multichannel ECG Recorder H4.