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DRAGERWERK AG & CO. KGAA

Germany · Pittsburgh

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Israel — 7 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

49registered devices

Class I 4Class II 45

59 including historic records

SASaudi ArabiaSFDA

15registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

78device registrations

CLASS B 47CLASS C 31

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

198active ARTG entries

Class I 47IIa 82IIb 68Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

13registrations

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 States0 registration records, 5 510(k), 0 PMA

Brazil49 confirmed, 0 excluded

Saudi Arabia15 confirmed, 0 excluded

Manufacturer names merged into this page: DRAGERWERK AG & CO. KGAA · Dragerwerk AG & Co. KGaA · Dragerwerk AG Co KGaA

Registration details (sample)

Market	Identifier	Name	Class / date
US	K182859	Babyleo TN500	2019-02-22
US	K180779	Savina 300	2019-01-17
US	K913394	INCUBATOR 8000 IC	1991-11-22
BR	10303949027	HI-Flow Star	Class II
BR	10303949028	Sistema HI-Flow Star	Class II
BR	10303949029	VentStar Helix Aquecido N Plus	Class II
SA	ME0000006565SFDAA00037	Neonatal Test Lung, reusable	—
SA	ME0000006565SFDAA00008	38 mm pole	—

DRAGERWERK AG & CO. KGAA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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