FDA Registration
Active
🇵🇱 Poland
Kimball Electronics Poland Sp.z o.o
Reg #: 3008058135
·
FEI: 3008058135
·
Expires 2026
Products
36
Proprietary Names
43
Establishment Types
1
Classifications
36
Registration Details
- Registration Name
- Kimball Electronics Poland Sp.z o.o
- Registration Number
- 3008058135
- FEI Number
- 3008058135
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ul. Poznanska 1 C
- City
- Tarnowo Podgorne Wielkopolskie
- Country
- PL
Owner / Operator
- Firm Name
- KIMBALL SOLUTIONS GROUP, LLC
- Operator Number
- 9071700
- Address
- 1205 Kimball Blvd.
- City
- Jasper
- State
- IN
- Postal Code
- 47546
- Country
- US
US Agent
- Business Name
- KIMBALL ELECTRONICS Inc.
- Contact Name
- LOLA J. Steward
- Address
- 1205 Kimball Blvd.
- City
- Jasper
- State
- IN
- ZIP
- 47546
- Country
- US
- [email protected]
- Phone
- 812 6344172
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2011-10-17 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-02-26 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2008-03-27 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2008-03-27 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2008-03-27 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2008-03-27 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2008-03-27 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2026-04-28 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2026-04-28 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2026-04-28 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2026-04-28 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2026-04-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-04-28 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2026-04-28 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2026-04-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2026-04-28 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2026-04-28 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2026-04-28 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2026-04-28 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2026-04-28 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2026-04-28 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2026-04-28 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2026-04-28 |
| Analyzer, Spectrum, Electroencephalogram Signal | GWS | Class 1 | Neurology | No | 2026-04-28 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2026-04-28 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2026-04-28 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2026-04-28 |
| Tetrabromo-M-Cresolsulfonphthalein, Albumin | CJG | Class 2 | Clinical Chemistry | No | 2014-12-22 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-10-29 |
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
Remote Control
NEXTRA Fluid Management and Tissue Debridement System
Diastix
IntelliVue Dock
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)