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OVESCO ENDOSCOPY AG

Germany · Tubingen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

16listed device types

Class I 5Class II 11Class III 0

plus 38 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 1Class III 1

14 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

6device registrations

CLASS C 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

21active ARTG entries

Class I 2IIa 5IIb 9Class Is (sterile) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 1Class 2b 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 States38 registration records, 14 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Ovesco Endoscopy USA · OVESCO ENDOSCOPY AG

FDA 510(k) clearances by year

12010

22014

22015

12016

22017

12019

12020

12022

12024

22025

FDA listed device types

showing 8 of 16

Electrosurgical, Cutting & Coagulation & Accessories 1Forceps, Biopsy, Electric 1Endoscopic Irrigation/Suction System 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Snare, Flexible 1Endoscopic Electrosurgical Clip Cutting System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251562	OTSCneo System Set (100.03n-14n, 100.27n-31n)	2025-12-18
US	K242586	ArgoCap (200.52)	2025-05-22
US	K241858	BARS Set (100.60)	2024-08-26
BR	82214249020	AWC®duo	Class II
BR	82214249021	ArgoCap	Class II
BR	80102519068	INSTRUMENTOS ENDOSCÓPICOS OVESCO	Class II
CA	83907	OTSC RELOADER	Class III
CA	112232	OTSC TWIN GRASPER	Class II

OVESCO ENDOSCOPY AG

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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