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Getinge Disinfection, Inc.

Sweden · Vaxjo

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

2listed device types

Class I 1Class II 1Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

8device registrations

CLASS B 6CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

11active ARTG entries

Class I 5IIb 6

HKHong KongMDACS

7valid listings

Class II 3Class III 4

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 States2 registration records, 1 510(k), 0 PMA, 3 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: GETINGE DISINFECTION AB · GETINGE (LJUNGADALSGATAN) DISINFECTION AB · Getinge Disinfection AB

Registration details (sample)

Market	Identifier	Name	Class / date
US	K950566	DECOMAT 4656	1995-10-19
BR	80259110022	LAVADORA-DESINFECTORA GETINGE SERIE 88 Turbo	Class II
BR	80259110098	Lavadora-Desinfectora Getinge Série 88 Turbo, modelo 88-5	Class II
BR	80259110026	LAVADORA-DESINFECTORA GETINGE	Class II
SA	ME0000014920SFDAA00003	Drying Cabinet	—
SA	ME0000001253SFDAA00001	Drying Cabinet	—

Getinge Disinfection, Inc.

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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