DRAEGER SAFETY AG & CO. KGAA

FDA Device Registration & Listing · Luebeck Schleswig-Holstein, DE · Registration 3013036322

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013036322
FEI Number
3013036322
Entity Name
DRAEGER SAFETY AG & CO. KGAA
City/State/Country
Luebeck Schleswig-Holstein, DE
Establishment Address
Revalstrasse 1, Luebeck Schleswig-Holstein 23560, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Draeger Safety AG & Co. KGaA (Owner Number: 10052315)
Owner / Operator Contact Address
Revalstrasse 1, Luebeck, DE-SH 23560, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Draeger Alcotest 3820 Draeger Alcotest 5820 Draeger Alcotest 5000 Draeger Sorb

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2016-07-14
CBL Absorbent, Carbon-Dioxide Anesthesiology Class 1 868.5300 2023-07-21

Official Correspondent

Thomas von Hoegen

US Agent Details

Mike Kelhart Business: Draeger, Inc. Email: mike.kelhart@draeger.com Phone: (215) 6602349

Related Public Records

Same Entity

Draeger Safety AG & Co. KGaA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013036322. Last updated year: 2026. Please use registration number 3013036322 when referencing this establishment in official correspondence.
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