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OERTLI INSTRUMENTE AG

Switzerland · Berneck

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 8 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

3listed device types

Class I 0Class II 3Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class III 4

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

20active ARTG entries

Class I 5IIa 11IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 States2 registration records, 2 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: OERTLI INSTRUMENTE AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233398	Faros Surgical System	2024-06-27
US	K133562	CATARHEX 3	2014-08-12
BR	80192019018	MD0105.102 Tubing Sets Single Pump System Reusable	Class II
BR	80192019019	Ponteiras de facoemulsificação reutilizáveis Oertli (MD0105.121)	Class II
BR	80192019020	MD0105.21 KIT DE ACESSÓRIOS DE FACOEMULSIFICAÇÃO OERTLI USO ÚNICO	Class II
CA	23257	CATARHEX SYSTEM	Class III
CA	24423	KLOTI RF EYE SURGERY SYSTEM	Class III
CA	23381	OS3 OPHTHALMIC SMALL-INCISION SURGERY SYSTEM	Class III

OERTLI INSTRUMENTE 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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