Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Netherlands›ESAOTE EUROPE BV

ESAOTE EUROPE BV

Netherlands · Maastricht
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
12active device licences
Class II 3Class III 9
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States0 registration records, 7 510(k), 0 PMA, 8 excluded
Brazil0 confirmed, 2 excluded
Canada12 confirmed, 2 excluded
Manufacturer names merged into this page: ESAOTE EUROPE BV
Same-named companies — This database also contains companies with near-identical names: Esaote Europe B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Maastricht

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

22006 · K062598
12007 · K070903
12009 · K083882
12010 · K101605
12014 · K141486
12016 · K161168

Registration details (sample)

MarketIdentifierNameClass / date
USK161168MyLabSix Ultrasound System2016-09-02
USK141486MYLABSIX ULTRASOUND SYSTEM2014-07-11
USK101605MYLABONE ULTRASOUND SYSTEM2010-08-31
CA20303ULTRASOUND IMAGING UNITSClass III
CA20304ULTRASOUND IMAGING DATA TRANSFER SYSTEMClass II
CA36538PICUS ULTRASOUND SYSTEMClass III

Similar companies

Advantech Europe B.V.
Netherlands · markets 2
ASO Europe B.V.
Netherlands · markets 2
ATRO Medical BV
Netherlands · markets 0
Axxicon BV
Netherlands · markets 0
BAP Medical B.V. SKIN - SCAR - NOSE - WOUND
Netherlands · markets 1
Bondus BV
Netherlands · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →