Dragerwerk AG
FDA registration: United States Last updated 23 May 2026
- Devices
- 699
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Perseus A500 MK06000 Ref MK06000
VentStar humidifier chamber (N) MP02590 Ref MP02590
Babylog VN600 8422200 Ref 8422200
ID Coax 180 MP03375 Ref MP03375
ECG Neo Defib TRUNK 3-LEADS 2.5M 2612027 Ref 2612027
HME HumidStar 25 Plus MP05735 Ref MP05735
Mask SediStar 6 w/o hook MP01706 Ref MP01706
NBP Cuff XS, 12-19cm MP00912 Ref MP00912
Mask ComfortStar3, b.gum, w.hook MP01533 Ref MP01533
Breathing bag 0.5L ISO with ho 2165763 Ref 2165763
Disposable Handle Polaris, Dual MP05700 Ref MP05700
Disposable CO2 cuvette, adult MP01062 Ref MP01062
Caleo starter kit MP01426 Ref MP01426
Babytherm 8004 System 2M22370 Ref 2M22370
Disposable Handle Polaris, Single MP05701 Ref MP05701
ECG 3-Lead single pin AHA 1m 2612001 Ref 2612001
Headgear disp., soft farbic, sm. MP01559 Ref MP01559
ECG 3-Lead single-pin EURO, 1m MP03401 Ref MP03401
Drägersorb FREE (5L) MX50050 Ref MX50050
VentStar Anesth (P) oLL (BagCone OD22) MP16031 Ref MP16031
Invasive VentPack Mini MP01671 Ref MP01671
VentstarCoaxWatertrap210 MP00373 Ref MP00373
VentStar Anesth Basic 180 (BagCone OD22) MP16033 Ref MP16033
ECG 5-Lead dual-pin EURO, 1.5m MP03413 Ref MP03413
HI-Flow Star Adult L MP05513 Ref MP05513
Hose kit F&P 8411041 Ref 8411041
VentStar Oxylog 3000F (P) 190 5704964 Ref 5704964
VentStar Anesth WT (P)180 (BC OD22) MP16037 Ref MP16037
HME HumidStar Trach Plus MP05750 Ref MP05750
ECG MonoLead 3, AHA/US 4.1m MP05131 Ref MP05131
Scio Four, Oxi plus 6871801 Ref 6871801
Mask ComfortStar6, mint, w.hook MP01546 Ref MP01546
Pressure reducer O2, PININDEX, Primus 8603466 Ref 8603466
Cap M (medium a 5pcs) 8418535 Ref 8418535
Filter/HME TwinStar 55 MP01805 Ref MP01805
Mask nonreb O2Star w tube S MP01930 Ref MP01930
Mask LiteStar4 w/o hook MP01504 Ref MP01504
Photo-Therapy 4000 2M22310 Ref 2M22310
Hook ring LITESTAR, 15mm, conn. MP01551 Ref MP01551
Mask ComfortStar0stand, w.hook MP01510 Ref MP01510
BlueSet Ventilation HME (P/A) 8412860 Ref 8412860
Anesthesia Set Flex Latex MP00304 Ref MP00304
ECG 3-Lead single-pin AHA, 1m MP03402 Ref MP03402
ID Bag Set 150 MP01330 Ref MP01330
NBP Cuff S, 17-25/29cm, Box10 MP00926 Ref MP00926
BabyFlow M, Box 20 MP03701 Ref MP03701
Anesthesia Circuit Kit Flex 3 MP02739 Ref MP02739
ECG MonoLead 6, AHA/US 5.7m MP05135 Ref MP05135
VentStar Coax Watertrap 200 MP00378 Ref MP00378
EKG 5-adrig TruST AHA, Telem. MP03424 Ref MP03424
Showing 101-150 of 699
What Dragerwerk AG makes
Dragerwerk AG manufactures medical equipment including oxymeters and the Incubator 8000 and Incubator 8000 IC models.
These devices are classified as Class II medical products and are listed in the FDA 510(k) registry, with the company maintaining operations in the US.
Frequently asked questions
What types of medical equipment does Dragerwerk AG manufacture?
Dragerwerk AG manufactures a range of medical equipment designed for clinical environments. Their product portfolio includes oxymeters as well as the Incubator 8000 and Incubator 8000 IC models, which are specialized devices used for patient care.
Where is Dragerwerk AG based?
Dragerwerk AG maintains operations within the United States. This location serves as the base for their activities related to the medical devices they manufacture and distribute.
How are the medical devices from Dragerwerk AG classified?
The medical devices produced by Dragerwerk AG, specifically the oxymeters and the Incubator 8000 series, are classified as Class II medical products. This classification is based on the regulatory framework applied to these specific types of equipment.
In which registries are the devices from Dragerwerk AG listed?
The medical devices manufactured by Dragerwerk AG are listed in the FDA 510(k) registry. This registry tracks devices that have undergone the 510(k) submission process to demonstrate their regulatory status in the United States.
Information
- FDA registration
- United States