RHONDIUM LIMITED

New Zealand · Katikati

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia — 5 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 1Class II 0Class III 0unclassified 1

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 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

1active device licences

Class III 1

2 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 2 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: RHONDIUM LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162677	L- OVC	2016-12-21
US	K143694	Rhondium One-Visit-Crown(OVC)	2015-05-15
BR	10334219002	Matriz Odontológica Rhondium	Class II
BR	10334219003	Cunha Odontológica Rhondium	Class II
CA	100215	OVC ONE VISIT CROWN LITHIUM	Class III

RHONDIUM LIMITED

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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