Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005792925

FEI Number

3005792925

Entity Name

TEM Innovations GmbH

City/State/Country

Munich Bavaria, DE

Establishment Address

Martin-Kollar Strasse, 15, Munich Bavaria 81829, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TEM Innovations GmbH (Owner Number: 10031957)

Owner / Operator Contact Address

Martin-Kollar-Strasse 15, Munich, DE-BY 81829, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201440

PMA Number

N/A

All Registered Proprietary Names

ROTROL P ROTROL N NATEM Assay in-TEM Assay hep-TEM Assay ROTEM Delta Instrument star-TEM EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET ROTEM sigma Thromboelastometry System ROTEM sigma ROTROL P ROTEM sigma complete + hep ROTEM sigma ROTROL N

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2010-03-25
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2010-03-25
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2011-09-19
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2022-09-29

Official Correspondent

David Jacob

US Agent Details

Keith Kelly Email: kkelly2@werfen.com Phone: (732) 3792123

Related Public Records

Same Entity

TEM Innovations 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
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0032-06	BIOMERIEUX, INC.	2	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.

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3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
2184009	MEDTRONIC PERFUSION SYSTEMS	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005792925. Last updated year: 2026. Please use registration number 3005792925 when referencing this establishment in official correspondence.