Dragerwerk AG
FDA registration: United States Last updated 23 May 2026
- Devices
- 699
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
Mask ClassicStar, NIV, w/AAV, S MP01570 Ref MP01570
Prong S (pack of 10pcs.) 8418605 Ref 8418605
Receptacle 2M85594 Ref 2M85594
Headgear reus., SI, small MP01557 Ref MP01557
Fabius Tiro 8606000 Ref 8606000
Breathing hose 22/22 (A)25 8604916 Ref 8604916
Cap XL (extra large 5 pcs) 8418537 Ref 8418537
Filter CareStar 35 Plus MP05755 Ref MP05755
VacuSmart 700ml MX23023 Ref MX23023
Evita VPack inv w CO2 Cuvette MP01656 Ref MP01656
ECG Neo ESU TRUNK 3-LEADS 1.5M 2612028 Ref 2612028
NeoMaskL 8418619 Ref 8418619
Mask ComfortStar4 Straw.w.hook MP01524 Ref MP01524
HME HumidStar 2 MP01745 Ref MP01745
ErgoStar AC 90 MP01890 Ref MP01890
Nasal canul O2Star straight M MP02921 Ref MP02921
Mask LiteStar 5 w/o hook MP11005 Ref MP11005
Mask SediStar 5 w/o hook MP01705 Ref MP01705
Secretion control glass M07582 Ref M07582
Pressure reducer N2O, PININDEX, Primus 8603462 Ref 8603462
Inf.ID Breath.CircuitSm. 300 MP04804 Ref MP04804
D-Vapor M35500 Ref M35500
Mask ClassicStar Nasal NV, M MP01624 Ref MP01624
Draeger Gemina DUO G16666 Ref G16666
Atlan A350 XL 8621600 Ref 8621600
Nasal canul O2Star flared S MP02928 Ref MP02928
Cap (11 Mm) 8401644 Ref 8401644
Mask nonreb O2Star w tube M/L MP01920 Ref MP01920
Ventstar ID coax GSL 230 MP00357 Ref MP00357
VentStar Anesthesia (N) 180 (cone OD22) MP16032 Ref MP16032
Neonatal flow sensor, Y-piece 8410185 Ref 8410185
Anesthesia Set Coax GSL 230 MP00358 Ref MP00358
Vacusmart Tube (2m) MP14010 Ref MP14010
ECG 6-Lead TruST EURO, Telem. MP03425 Ref MP03425
Mask ClassicStar Nasal NV, S MP01623 Ref MP01623
Headgear S, Box 5 MP03882 Ref MP03882
Mask LiteStar 2 w/o hook MP11002 Ref MP11002
VarioVac MRI B/OR rail MP03222 Ref MP03222
Filter CareStar 45 MP01755 Ref MP01755
Breathing hose 22/10 (N/P) 60 2165821 Ref 2165821
Bacteria filter 767 ST 6723976 Ref 6723976
Mask SediStar 1 w/o hook MP01701 Ref MP01701
ECG Monolead 6, AHA/US 3m MP05125 Ref MP05125
Polaris 100/200 G16980 Ref G16980
Double Cone 11A 8409897 Ref 8409897
Fabius OS 8608300 Ref 8608300
Nasal canul O2Star flared L MP02930 Ref MP02930
Mask ComfortStar4, mint, w.hook MP01544 Ref MP01544
VentStar Carina ExpV 200cm 5704962 Ref 5704962
Infinity ID WaterLock2 6872020 Ref 6872020
Showing 151-200 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