HomeUSARmo, Inc.

Rmo, Inc.

USA · Johor Bahru
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, South Korea, Hong Kong, Israel — 7 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
38listed device types
Class I 27Class II 11Class III 0
plus 52 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
10registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
3valid listings
Class II 3
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 States52 registration records, 1 510(k), 0 PMA
Brazil0 confirmed, 3 excluded
Saudi Arabia10 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: RMO · RMO, Inc.

Company information

Country
USA
City
Johor Bahru

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

11990 · K902050

FDA listed device types

showing 8 of 38
Ventilator, Non-Continuous (Respirator) 1Activator, Ultraviolet, For Polymerization 1Adhesive, Bracket And Tooth Conditioner, Resin 1Bracket, Ceramic, Orthodontic 1Headgear, Extraoral, Orthodontic 1Material, Tooth Shade, Resin 1Material, Impression 1Alloy, Other Noble Metal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK902050BIOLASTIC SUPER ELASTIC ARCHES1990-08-03
SAME0000012069SFDAA00001RMO
SAME0000012069SFDAA00002RMO

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