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FYSICON BV

Netherlands · Oss Noord-Brabant
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, South Korea, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 2 510(k), 0 PMA
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: FYSICON BV · Fysicon BV

Company information

Country
Netherlands
City
Oss Noord-Brabant

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12017 · K170032
12025 · K241766

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Computer, Diagnostic, Programmable 1Medical Device Data System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)2025-08-27
USK170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP2017-09-08
SAME0000001375SFDAA00001DataLinQ 2PAD—
SAME0000001375SFDAA00002DataLinQ Standalone—

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