HomeUSARIGICON, INC.

RIGICON, INC.

USA · Ronkonkoma
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 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
7listed device types
Class I 3Class II 1Class III 3
plus 14 registration records and 1 510(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
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 2IIb 4Class Is (sterile) 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States14 registration records, 1 510(k), 0 PMA
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: RIGICON, INC. · RIGICON AS

Company information

Country
USA
City
Ronkonkoma

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

12019 · K181673

FDA listed device types

Prosthesis, Penis, Inflatable 1Prosthesis, Testicular 1Prosthesis, Urethral Sphincter 1Penile Implant Surgical Accessories 1Surgical Instruments, G-U, Manual (And Accessories) 1Retractor 1Prosthesis, Penile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181673Rigi10 Malleable Penile Prosthesis2019-04-15

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