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ENDO-THERAPEUTICS, INC.

USA · Clearwater

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel — 6 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

14listed device types

Class I 3Class II 11Class III 0

plus 15 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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 II 1

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States15 registration records, 9 510(k), 0 PMA, 37 excluded

Brazil3 confirmed, 22 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada1 confirmed, 6 excluded

Manufacturer names merged into this page: ENDO-THERAPEUTICS, INC. · ENDO TOOLS THERAPEUTICS S.A

FDA 510(k) clearances by year

21993 · K926549

22001 · K012725

22003 · K031026

12009 · K090796

12021 · K211309

12026 · K252400

FDA listed device types

showing 8 of 14

Endoscopic Injection Needle, Gastroenterology-Urology 1Endoscopic Tissue Approximation Device 1Instrument, Biopsy 1Forceps, Biopsy, Electric 1Bottle, Collection, Vacuum 1Forceps, Biopsy, Bronchoscope (Non-Rigid) 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252400	Endomina EZFuse system	2026-02-13
US	K211309	endomina system	2021-12-07
US	K090796	MULTI-BITE HOT BIOPSY FORCEPS	2009-11-25
BR	80375540005	PINÇA ENDOSCÓPICA	Class I
BR	80375540004	ESCOVA DE CITOLOGIA	Class I
BR	80375540009	PINÇA ENDOSCÓPICA DESCARTÁVEL XENTURA	Class I
CA	74591	TRIPOD GRASPER	Class II

ENDO-THERAPEUTICS, 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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