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Orametrix, Inc.

Germany · Berlin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

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

3active device licences

Class II 3

6 including historic records

TWTaiwanTFDA

6valid device licences

Class I 4Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

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 States1 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: OraMetrix GmbH · ORAMETRIX GMBH · ORAMETRIX

Registration details (sample)

Market	Identifier	Name	Class / date
US	K002620	SURESMILE SYSTEM	2000-11-16
BR	80196880451	SureSmile Retainer	Class I
BR	80196880439	SURESMILE SOFTWARE	Class II
BR	80196880440	SureSmile Aligner	Class I
CA	73889	CUSTOMIZED ARCHWIRES - TITANIUM	Class II
CA	73890	CUSTOMIZED ARCHWIRES	Class II
CA	100819	CUSTOMIZED ALIGNERS	Class II

Orametrix, 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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