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REGER Medizintechnik GmbH

Germany · Villingendorf · www.reger-medical.de

✓ Record-verifiedregistrations found in 9 marketsEU SRN DE-MF-000005910

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Israel — 9 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

1UDI-DI device records

Class IIb 1

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 1Class IIa 1Class IIb 3

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

European Union1 raw hits, 0 excluded, 1 confirmed

United States0 registration records, 1 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: REGER MEDIZINTECHNIK GMBH · REGER Medizintechnik GmbH

Regulatory identity

EU manufacturer SRN: DE-MF-000005910
UK responsible person: MEDAGENT INTERNATIONAL UK LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04250646107472	—	Class IIb
UK	60502	Nebulizer	Class IIa
UK	47487	Bipolar HF Cable	Class I
UK	61872	Endoscopic electrosurgical electrode, bipolar, single-use	Class IIb
US	K231622	REGER Nebulizer Irrigation Cannula	2023-09-29
BR	80014440007	Nebulizer	Class II
SA	ME0000001861SFDAA00001	Bipolar connection cable with pencil	—

REGER Medizintechnik GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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