HomeUSAIcrco, Inc.

Icrco, Inc.

USA · Goleta
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 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
11listed device types
Class I 3Class II 8Class III 0
plus 14 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
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
1 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 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 States14 registration records, 5 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: iCRco Inc. · ICRCO INC. · ICRCO, INC.

Company information

Country
USA
City
Goleta

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

12009 · K082450
22012 · K120753
12013 · K122510
12014 · K132499

FDA listed device types

showing 8 of 11
System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Camera, Multi Format, Radiological 1Full Field Digital, System, X-Ray, Mammographic 1System, X-Ray, Stationary 1Digitizer, Image, Radiological 1X-Ray, Tomography, Computed, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK132499ICRCO CLARITY VIEWER2014-01-21
USK122510ICRCO 3600M2013-04-26
USK120753CLARISCT2012-07-26
BR81423030001ChromeClass I
BR81423030004ICRClass I

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