HomeKorea, RepublicH ROBOTICS INC

H ROBOTICS INC

Korea, Republic · Incheon · www.hroboticsincsinc.com
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Hong Kong, Israel, Russia — 6 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
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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.

European Union312 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States2 registration records, 0 510(k), 0 PMA, 43 excluded
United Kingdom0 confirmed, 10 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia1 confirmed, 2 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: H ROBOTICS INC. · H Robotics Inc.

Company information

Country
Korea, Republic
City
Incheon
Website
www.hroboticsincsinc.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationAssistive mobility technologies

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 listed device types

Exerciser, Powered 1System, Isokinetic Testing And Evaluation 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000004971SFDAA00001Rebless

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