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Geratherm Respiratory GmbH

China · Tianjin · www.geratherm-respiratory.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN DE-MF-000006818

This company has registrations in European Union, United Kingdom, Brazil, Singapore, Australia, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

16UDI-DI device records

Class I 6Class IIa 10

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 3Class IIa 5

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union42 raw hits, 26 excluded, 16 confirmed

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom8 confirmed, 1 excluded

Brazil2 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: GERATHERM RESPIRATORY GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000006818
UK responsible person: Love Medical Ltd
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04065803201005	Diffustik	Class IIa
EU	04065803003005	Spiraflow & Softclip Set	Class I
EU	04065803301019	Ambistik CPET	Class I
EU	04065803301002	Ambistik PFT	Class I
UK	36146	Cardiopulmonary stress exercise monitoring system	Class IIa
UK	13680	Diagnostic spirometer, professional	Class IIa
UK	36989	Environmental sensor	Class I
BR	80200269010	Pletismógrafo com difusão	Class II
BR	80200269002	BOCAL DESCARTÁVEL PARA ESPIRÔMETRO GERATHERM	Class I

Geratherm Respiratory GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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