Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008058135

FEI Number

3008058135

Entity Name

Kimball Electronics Poland Sp.z o.o

City/State/Country

Tarnowo Podgorne Wielkopolskie, PL

Establishment Address

ul. Poznanska 1 C, Tarnowo Podgorne Wielkopolskie 62-080, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KIMBALL SOLUTIONS GROUP, LLC (Owner Number: 9071700)

Owner / Operator Contact Address

1205 Kimball Blvd., Jasper, IN 47546, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FMS Tornado Micro II Hand Controlled Shaver Handpiece FMS Tornado Micro II No-button Shaver Handpiece FMS DUO Fluid Management System FMS Tornado Micro Handpiece with buttons SureTemp Box Set CADINAL HEALTH Predictive Temperature Module FMS VUE II Fluid Management and Tissue Debridement System CLINITEK Advantus Multistix 10 Multistix Pro 10 LS Labstix SG N-Labstix N-Multistix SG Multistix GP Microalbustix Combistix SG Multistix Pro Reagent Strip Family Multistix 9 Albustix Labstix Multistix Combistix Multistix 10 SG Azostix Uristix Uristix 4 Multistix 8 SG Hema-Combistix Multistix 5 Multistix 9 SG Multistix 7 Ketostix Keto-Diastix Hemastix IntelliVue Measurement Rack 6000 FMS VUE Fluid Management and Tissue Debridement System FMS Connect Interface Cable VUE Clinitek Microalbumin 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-10-17
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-02-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-02-27
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2008-03-27
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2008-03-27
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2008-03-27
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2008-03-27
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-03-27
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2008-03-27
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2008-03-27
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-03-27
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2008-03-27
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2008-03-27
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2008-03-27
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2008-03-27
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2007-12-04
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2007-12-04
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2007-12-04
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2007-12-04
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2007-12-04
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2007-12-04
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-12-04
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2007-12-04
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2007-12-04
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2007-12-04
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2007-12-04
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2010-03-04
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2007-11-29
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2026-04-28
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-04-28
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2026-04-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-04-28
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-04-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-28
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-04-28
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-04-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-04-28
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2026-04-28
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-04-28
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-04-28
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2026-04-28
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-04-28
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-04-28
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2026-04-28
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2026-04-28
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-04-28
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2026-04-28
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2026-04-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-05-16
CJG	Tetrabromo-M-Cresolsulfonphthalein, Albumin	Clinical Chemistry	Class 2	862.1035	2014-12-22
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2014-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

LOLA J. Steward Business: KIMBALL ELECTRONICS Inc. Email: Lola.Steward@kimballelectronics.com Phone: (812) 6344172

Related Public Records

Same Entity

KIMBALL SOLUTIONS GROUP, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027241818	Kimball Electronics - Mexico SA de CV	Reynosa Tamaulipas, MX
3008253300	Kimball Solutions Jasper, Inc.	Jasper, IN, US
3003660459	Kimball Electronics - Thailand LTD	Thungsukhla Sriracha Chon Buri, TH
3004598644	Kimball Electronics - Indianapolis	Indianapolis, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K012065	Wiener Laboratories Saic	WIENER LAB. CREATININA CINETICA AA	2001-10-10
K183555	Instrumentation Laboratory CO	GEM Premier ChemSTAT	2019-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0008-2009	Roche Diagnostics Corp.	2	Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008058135. Last updated year: 2026. Please use registration number 3008058135 when referencing this establishment in official correspondence.