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TOP CORPORATION

Japan · Tokyo
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
5listed device types
Class I 1Class II 4Class III 0
plus 8 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class II 11
13 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
TWTaiwanTFDA
4valid device licences
Class I 1Class II 3
SGSingaporeHSA SMDR
8device registrations
CLASS B 4CLASS C 3CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 4
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
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 States8 registration records, 4 510(k), 0 PMA, 47 excluded
Brazil11 confirmed, 9 excluded
Saudi Arabia0 confirmed, 17 excluded
Canada3 confirmed, 3 excluded
Manufacturer names merged into this page: TOP CORPORATION

Company information

Country
Japan
City
Tokyo

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

11986 · K860449
12007 · K062946
12008 · K080771
12019 · K182765

FDA listed device types

Set, Administration, Intravascular 1Anesthesia Conduction Kit 1Syringe, Piston 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Patient Personal Hygiene Kit 1

Registration details (sample)

MarketIdentifierNameClass / date
USK1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe2019-09-03
USK080771TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC2008-11-10
USK062946TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL2007-02-15
BR81022039002Kit Introdutor Ecogênico para Bloqueio RU TOPClass II
BR81704069044INTRODUTOR CANULADO ALEXANDRE TEIXEIRAClass II
BR81704069046INTRODULOR CANULADO NESFIELDClass II
CA72255TOP NEUROPOLE NEEDLES FOR REGIONAL ANESTHESIAClass II
CA72256TOP NEUROPOLE NEEDLES FOR PAIN MANAGEMENTClass II
CA84858TOP GLASS SYRINGEClass II

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