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DRAEGERWERK AG & CO. KGAA

Germany · Lubeck

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Hong Kong, Israel — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

48listed device types

Class I 19Class II 29Class III 0

plus 91 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

32active device licences

Class II 9Class III 23

140 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

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.

United States91 registration records, 13 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada32 confirmed, 0 excluded

Manufacturer names merged into this page: DRAEGERWERK AG & CO. KGAA · Draegerwerk AG & Co. KGaA · Drägerwerk AG & Co. KGaA · DRÄGERWERK AG & CO. KGAA

FDA 510(k) clearances by year

12010

12017

12022

52023 · K230931

22025 · K252827

32026 · K252746

FDA listed device types

showing 8 of 48

System, Network And Communication, Physiological Monitors 1Bottle, Collection, Vacuum 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Incubator, Neonatal 1Humidifier Nebulizer Kit 1Ventilator, Continuous, Facility Use 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252746	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
US	K253647	Evita (V800); Evita (V600)	2026-05-07
US	K251619	Babyleo TN500	2026-02-13
BR	10303940050	Polaris	Class I
BR	10303949050	Máscara Oronasal NIV ClassicStar Plus	Class II
BR	10303949041	Máscara facial completa NIV ClassicStar com válvula contra asfixia (AA	Class II
CA	8596	RESPICARE	Class II
CA	8601	DRAGER MEDICAL AIR COMPRESSOR	Class II
CA	8971	S PLUS	Class II

DRAEGERWERK AG & CO. KGAA

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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