# Draegerwerk AG & Co. KGaA (manufacturer, LUEBECK Schleswig-Holstein, DE): 5 new FDA device listings, incl. support, breathing tube

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Draegerwerk AG & Co. KGaA |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | LUEBECK Schleswig-Holstein, DE |
| New listings | 5 |
| Devices | Support, Breathing Tube; Warmer, Infant Radiant; Bilirubin (Total And Unbound) In The Neonate Test System; Ventilator, Continuous, Facility Use; Gas-Machine, Anesthesia |
| Product codes | JAY, FMT, MQM, CBK, BSZ |
| Device classes | Class I, Class II |
| Medical specialties | Anesthesiology, General Hospital, Clinical Chemistry |
| Brand names | Hinged Arms; Babyroo TN300; DRAEGER JAUNDICE METER JM-105; Evita V800 Evita V600; Atlan A350; Atlan A350 XL; Atlan A100 XL; Atlan A100 |
| First new listing | 2026-05-15 |
| Latest new listing | 2026-08-06 |
| FDA registration number | 9611500 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.