LAUDA DR. R. WOBSER GMBH & CO. KG

FDA Device Registration & Listing · Laudaplatz 1 Baden-Wurttemberg, DE · Registration 3001588119

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
3001588119
FEI Number
3001588119
Entity Name
LAUDA DR. R. WOBSER GMBH & CO. KG
City/State/Country
Laudaplatz 1 Baden-Wurttemberg, DE
Establishment Address
Lauda-Koeningshofen, Laudaplatz 1 Baden-Wurttemberg 97922, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
LAUDA DR. R. WOBSER GMBH & CO. KG (Owner Number: 10049791)
Owner / Operator Contact Address
97912 Lauda-Koeningshofen, Laudaplatz 1, Lauda-Koenigshofen, DE-BW 97922, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stoeckert Heater-Cooler System 3T

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2021-04-27

Official Correspondent

Juergen Kraus

US Agent Details

Michael Faulkner Business: LAUDA-Brinkmann, LP Email: M.Faulkner@lauda-brinkmann.com Phone: (631) 8737998

Related Public Records

Same Entity

LAUDA DR. R. WOBSER GMBH & CO. KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K001520 Alpha Omega, Inc. ALPHA OMEGA DUAL COOLER-HEATER 2000-11-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001588119. Last updated year: 2026. Please use registration number 3001588119 when referencing this establishment in official correspondence.
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