HomeUnited Kingdom of Great Britain and Northern IrelandBODYSTAT LIMITED

BODYSTAT LIMITED

United Kingdom of Great Britain and Northern Ireland · Douglas
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 7 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
2listed device types
Class I 0Class II 2Class III 0
plus 5 registration records and 8 510(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
1active device licences
Class II 1
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States5 registration records, 8 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: BODYSTAT LTD · BODYSTAT LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Douglas

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

11995
11997
11998
12000
12001
12008
22011

FDA listed device types

Analyzer, Body Composition, Exempt 1Analyzer, Body Composition 1

Registration details (sample)

MarketIdentifierNameClass / date
USK082254MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT2011-02-07
USK082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT2011-02-07
USK082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT2008-11-25
CA82066BODYSTAT CE ELECTRODESClass II

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