Draegerwerk AG & Co. KGaA
Country not established FDA establishment FEI 3001104093
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Catalogue
Evita (V800); Evita (V600) Ref K253647
510(k) 510(k)CO2 Mainstream Sensor Ref K221118
510(k) 510(k)Babyleo TN500 Ref K162821
510(k) 510(k)- 510(k) 510(k)
Babylog VN800, Babylog VN600 Ref K222207
510(k) 510(k)- 510(k) 510(k)
Evita V800, Evita V600 Ref K222024
CE MDR 510(k) 510(k)- 510(k) 510(k)
Company details
- FDA FEI number
- 3001104093
- Address
- 53/55 MOISLINGER ALLEE, LUEBECK Schleswig-Holstein
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 17 Nov 2023 Z-0971-2024 Class II Ongoing Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.
Full distribution text
- 17 Nov 2023 Z-0971-2024 Class II Ongoing Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.
Frequently asked questions
How many devices does Draegerwerk AG & Co. KGaA have in the registry?
The registry currently lists 8 devices for Draegerwerk AG & Co. KGaA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Draegerwerk AG & Co. KGaA's devices?
Among its 8 most recently registered devices, Draegerwerk AG & Co. KGaA has devices listed in FDA 510(k) (8 devices).
What risk classes do Draegerwerk AG & Co. KGaA's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Draegerwerk AG & Co. KGaA's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Draegerwerk AG & Co. KGaA?
FDA recall records list 1 recall initiated by Draegerwerk AG & Co. KGaA, the most recent initiated on 2023-11-17. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Draegerwerk AG & Co. KGaA in the registry?
The most recently registered devices listed for Draegerwerk AG & Co. KGaA include Evita (V800); Evita (V600), CO2 Mainstream Sensor, Babyleo TN500 and VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031).