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Jaeger Medical GmbH

Germany · Hoechberg

✓ Record-verifiedregistrations found in 8 markets

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

30listed device types

Class I 7Class II 23Class III 0

plus 87 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 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

8active device licences

Class II 7Class III 1

22 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

Class I 1IIa 7

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

pendingnot queried

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 States87 registration records, 0 510(k), 0 PMA, 4 excluded

Brazil3 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: Jaeger Medical America Inc. · Jaeger Medical GmbH · JAEGER MEDICAL GMBH

FDA listed device types

showing 8 of 30

Calibrator, Volume, Gas 1Mouthpiece, Breathing 1Regulator, Pressure, Gas Cylinder 1Transducer, Gas Flow 1Clip, Nose 1Medical Device Data System 1Valve, Prosthesis 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80102519159	Sistema Diagnóstico de Função Pulmonar	Class II
BR	80102512071	DISPOSITIVO DE FUNÇÃO PULMONAR	Class II
BR	80102512313	Dispositivo de Função Pulmonar	Class II
CA	29234	MASTERSCREEN SYSTEM	Class II
CA	62961	CPAP FAMILY	Class II
CA	63655	SPIROSOFT	Class II

Jaeger Medical GmbH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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