HomeUSABOSS INSTRUMENTS, LTD.

BOSS INSTRUMENTS, LTD.

USA · Gordonsville
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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
160listed device types
Class I 150Class II 10Class III 0
plus 165 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 5
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
14active device licences
Class II 14
15 including historic records
TWTaiwanTFDA
8valid device licences
Class I 8
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
39active ARTG entries
Class I 34IIa 2IIb 1Class Im (measuring) 2
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 States165 registration records, 1 510(k), 0 PMA, 2 excluded
Brazil5 confirmed, 0 excluded
Canada14 confirmed, 1 excluded
Manufacturer names merged into this page: BOSS INSTRUMENTS, LTD. · BOSS INSTRUMENTS LTD

Company information

Country
USA
City
Gordonsville

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

11998 · K980002

FDA listed device types

showing 8 of 160
Chisel, Surgical, Manual 1Rod, Measuring Ear 1Stripper, Surgical 1Gag, Mouth 1Chisel, Bone, Surgical 1Chisel, Middle-Ear 1Tamp 1Spud, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK980002KOALA VASCULAR CLAMPS AND INSERTS1998-06-18
BR80353100014Kit de Retratores de Coluna Cervical IMAGE-LINE BossClass I
BR80353100021Instrumental Não Cortante Não Articulado BOSSClass I
BR80353100022Instrumental Articulado Não Cortante BOSSClass I
CA81150BIOPSY INSTRUMENTSClass II
CA81151SCISSORSClass II
CA81426ELECTROSURGICAL COAGULATION INSTRUMENTSClass II

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