FDA Registration
Active
🇩🇪 Germany
LRE MEDICAL GMBH
Reg #: 3003366417
·
FEI: 3003366417
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LRE MEDICAL GMBH
- Registration Number
- 3003366417
- FEI Number
- 3003366417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HOFER STRASSE 5
- City
- NOERDLINGEN Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K200533
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 |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-02-24 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)