FDA Registration
Active
🇩🇪 Germany
LRE MEDICAL GMBH
Reg #: 3003366417
·
FEI: 3003366417
·
Expires 2026
Products
11
Proprietary Names
7
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- LRE MEDICAL GMBH
- Registration Number
- 3003366417
- FEI Number
- 3003366417
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HOFER STRASSE 5
- City
- NOERDLINGEN Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- LRE MEDICAL GMBH
- Operator Number
- 9049285
- Address
- HOFER STRASSE 5, --
- City
- NOERDLINGEN
- State
- Bavaria
- Postal Code
- 86720
- Country
- DE
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd., Suite 200, Great Neck, NY 11021
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2019-05-22 |
| System, Test, Breath Nitric Oxide | MXA | Class 2 | Clinical Toxicology | No | 2024-05-16 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-02-24 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2006-05-08 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2006-05-08 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2006-05-08 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2006-05-08 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2017-11-02 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2006-05-08 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2006-05-08 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2006-05-08 |
Proprietary Names
QIAstat-dx® Analyzer 1
Vivatmo pro
TRIAGE METER
CT ExpresTM 3D Contrast Media Delivery System
UCHECK
ACCUCHECK INSTAND PLUS DUAL TESTING
ACCUCHECK
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)