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GESTENCO INTERNATIONAL AB

Sweden · Goteborg Vastra Gotaland

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Russia — 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

6listed device types

Class I 4Class II 2Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States6 registration records, 1 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: GESTENCO INTERNATIONAL AB · Gestenco International AB

FDA 510(k) clearances by year

12005 · K053055

FDA listed device types

Accessories, Retractor, Dental 1Protector, Dental 1Instruments, Dental Hand 1Bracket, Metal, Orthodontic 1Adhesive, Bracket And Tooth Conditioner, Resin 1Bracket, Plastic, Orthodontic 1

Market	Identifier	Name	Class / date
US	K053055	ORTHODONTIC POLYMER COMPOSITE BRACKET	2005-12-22
SA	ME0000001501SFDAA00003	DENTAL RETRACTOR	—

GESTENCO INTERNATIONAL AB

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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