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NDD MEDIZINTECHNIK AG

Switzerland · Zurich

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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 2Class II 3Class III 0

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 3IIa 6

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States10 registration records, 7 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: NDD MEDIZINTECHNIK AG · NDD Medizintechnik AG

FDA 510(k) clearances by year

12009 · K090034

12010 · K091428

12012 · K120635

22017 · K161534

12022 · K221250

12023 · K230178

FDA listed device types

Filter, Bacterial, Breathing-Circuit 1Spirometer, Diagnostic 1Calculator, Predicted Values, Pulmonary Function 1Mouthpiece, Breathing 1Transducer, Gas Flow 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230178	EasyOne Sky Spirometer	2023-10-19
US	K221250	EasyOne Filter	2022-11-22
US	K161534	EasyOne Pro Respiratory Analysis System	2017-02-22
BR	81492119004	ESPIRÔMETROS NDD	Class II
BR	81492119003	ESPIRÔMETRO - NDD	Class II
BR	10338760012	ESPIROMETRO ndd	Class II
SA	ME0000006871SFDAA00003	FRC Barriette	—
SA	ME0000006871SFDAA00002	DLCO Barriette	—
CA	66920	EASYONE SPIROMETRY UNITS	Class II

NDD MEDIZINTECHNIK 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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