HomeChinaBiotronics 3D Limited

Biotronics 3D Limited

China
✓ Record-verifiedregistrations found in 3 marketsEU SRN UK-MF-000051724

This company has registrations in European Union, United States, United Kingdom — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
1UDI-DI device records
Class IIa 1
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
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
0active device licences
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.

European Union1 raw hits, 0 excluded, 1 confirmed
United States1 registration records, 0 510(k), 0 PMA, 3 excluded
United Kingdom1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Biotronics 3D Limited

Regulatory identity

EU manufacturer SRN
UK-MF-000051724
EU authorised representative
Skyer Medical Imaging S.R.L.
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China

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 listed device types

System, Image Processing, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05060757520003Class IIa
UK416703DnetClass IIa

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