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ROHO, Inc.

USA · Belleville

✓ Record-verifiedregistrations found in 7 markets

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

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States7 registration records, 2 510(k), 0 PMA

Brazil4 confirmed, 1 excluded

Saudi Arabia9 confirmed, 0 excluded

Manufacturer names merged into this page: ROHO, Inc. · ROHO, INC. · ROHO Inc.

FDA 510(k) clearances by year

11986 · K861327

11992 · K923186

FDA listed device types

Cushion, Flotation 1Protector, Skin Pressure 1Cover, Mattress (Medical Purposes) 1Mattress, Flotation Therapy, Non-Powered 1Accessories, Wheelchair 1System, Pressure Measurement, Intermittent 1Components, Wheelchair 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K923186	NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC	1992-09-09
US	K861327	ROHO HEEL PAD	1986-06-02
BR	10292010063	Família de Almofadas Roho	Class I
BR	10292010062	Família de Colchões Roho	Class I
BR	80626470011	ROHO Hybrid	Class I
SA	ME0000008550SFDAA00021	HCARD, ROHO MATTRESS SYSTEM CUSTOM	—
SA	ME0000008550SFDAA00022	QUAD SELECT	—

ROHO, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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