Home›Israel›Tuttnauer Co. , Ltd.

Tuttnauer Co. , Ltd.

Israel · Beit-Shemesh

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

5listed device types

Class I 0Class II 5Class III 0

plus 20 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

0active device licences

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

6valid listings

Class III 6

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 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 States20 registration records, 10 510(k), 0 PMA, 3 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: TUTTNAUER LTD. · TUTTNAUER CO. LTD.

FDA 510(k) clearances by year

11984

11985

11993

12001

12007

12011

12019

32022

FDA listed device types

Indicator, Physical/Chemical Sterilization Process 1Indicator, Chemical, Enzymatic, Sterilization Process 1Device, Pasteurization, Hot Water 1Indicator, Biological Sterilization Process 1Sterilizer, Steam 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222608	Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS	2022-12-16
US	K221227	Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120	2022-09-20
US	K213080	T-Edge 10, T-Edge 11	2022-01-04
BR	80241710029	AUTOCLAVES COM CÂMARA CILÍNDRICA E PORTA TIPO ESCOTILHA	Class II
BR	80241710028	AUTOCLAVES COM CÂMARA PARALELEPIPEDAL E PORTA DESLIZANTE TUTTNAUER	Class II
BR	10357720013	AUTOCLAVE TUTTNAUER	Class II