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Endochoice, Inc.

Germany · Alpharetta

✓ Record-verifiedregistrations found in 5 markets

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

27510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

6active device licences

Class II 6

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States0 registration records, 27 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: ENDOCHOICE INC. · ENDOCHOICE GMBH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160275	Fuse Endoscopic System with FuseBox Processor	2016-08-01
US	K161482	EndoChoice Water Bottle Cap Irrigation System	2016-06-27
US	K161167	Seal Single-Use Biopsy Valve	2016-05-26
BR	80102511401	SISTEMA DE VÍDEO ENDOSCOPIA PARA DIAGNÓSTICO DO APARELHO DIGESTIVO	Class II
CA	80751	AUTO-BAND LIGATOR	Class II
CA	92378	FUSE 1G GASTROSCOPE	Class II
CA	92379	FUSE 1C COLONOSCOPE	Class II

Endochoice, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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