TCOAG DEUTSCHLAND GMBH

FDA Device Registration & Listing · LEMGO North Rhine-Westphalia, DE · Registration 3003943960

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
3003943960
FEI Number
3003943960
Entity Name
TCOAG DEUTSCHLAND GMBH
City/State/Country
LEMGO North Rhine-Westphalia, DE
Establishment Address
LEHBRINKSWEG 59,, LEMGO North Rhine-Westphalia 32657, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Tcoag Deutschland GmbH (Owner Number: 10032697)
Owner / Operator Contact Address
Lehbrinkweg 59, 32657, Lemgo, Lemgo, DE-NW 32657, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KC1 Delta KC4 Delta Destiny Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2010-06-09
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2010-06-09
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2010-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

Donald Kraft Business: Diagnostica Stago, Inc Email: donald.kraft@us.stago.com Phone: (973) 6311200

Related Public Records

Same Entity

Tcoag Deutschland GmbH
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
K924453 Organon Teknika Corp. MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) 1992-12-18

Related Recall Records

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VeriCal Calibrator Set
Z-0042-05 Dade Behring Inc. Rte 896, Glasgow Business Community 2
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05 bioMerieux 2
The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04 Instrumentation Laboratory Co. 2
ACL Futura Instrument Analyzer
Z-0737-04 Instrumentation Laboratory Co. 2
ACL Advance Instrument Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003943960. Last updated year: 2026. Please use registration number 3003943960 when referencing this establishment in official correspondence.
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