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Align Technology (Sichuan) Medical Equipment Co., Ltd.

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 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

15listed device types

Class I 10Class II 5Class III 0

plus 28 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 8Class II 4

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

SASaudi ArabiaSFDA

14registered imported devices

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

CACanadaMDALL

4active device licences

Class II 3Class III 1

25 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

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 States28 registration records, 15 510(k), 0 PMA, 6 excluded

Brazil12 confirmed, 1 excluded

Saudi Arabia14 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Align Technology, Inc. · Align Technology, Ltd. · ALIGN TECHNOLOGY INC. · ALIGN TECHNOLOGY, LTD. · ALIGN TECHNOLOGY, INC · Align Technology (Sichuan) Medical Equipment Co., Ltd.

FDA 510(k) clearances by year

11998

12008

12015

12018

12020

22022

22023

22024

32025

12026

FDA listed device types

showing 8 of 15

Intraoral Camera 1Light Transmission Caries Detector 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Orthodontic Software 1Aligner, Sequential 1Indirect Bonding Tray 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile 1Maintainer, Space Preformed, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261847	iTero Lumina Pro	2026-07-02
US	K252931	Invisalign® Palatal Expander System	2025-10-23
US	K252870	Invisalign Specifix Attachment System	2025-10-09
BR	80194750002	ALINHADORES DENTÁRIOS REMOVÍVEIS	Class I
BR	80194750008	Invisalign Lens	Class I
BR	80194750004	Alinhadores Ortodônticos Removíveis	Class I
SA	ME0000002687SFDAA00056	iTero Element 5D Plus	—
SA	ME0000002687SFDAA00058	iTero Element 5D Plus Mobile	—
CA	63330	INVISALIGN PONTIC KIT	Class II
CA	63365	INVISALIGN BUTTON KIT	Class II
CA	78580	INVISALIGN INTER-PROXIMAL REDUCTION KIT (IPR KIT)	Class II

Align Technology (Sichuan) Medical Equipment Co., Ltd.

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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