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ROKIT HEALTHCARE, INC.

Korea, Republic · Geumcheon-Gu Seoul

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel — 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

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States2 registration records, 0 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: ROKIT HEALTHCARE INC. · ROKIT HEALTHCARE, INC. · Rokit Healthcare, INC.

Market	Identifier	Name	Class / date
BR	80207459003	Dr. INVIVO 4D2D.	Class II
SA	ML0000000006SFDAA00011	Dr. INVIVO	—
SA	ML0000000006SFDAA00012	AiD Regen	—

ROKIT HEALTHCARE, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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