FDA Registration
Active
🇺🇸 United States
Typenex Medical, LLC
Reg #: 3005720829
·
FEI: 3005720829
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- Typenex Medical, LLC
- Registration Number
- 3005720829
- FEI Number
- 3005720829
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 300 E Randolph St Ste 40.100
- City
- Chicago
- State
- IL
- ZIP
- 60601
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK150351
Owner / Operator
- Firm Name
- Typenex Medical, LLC
- Operator Number
- 10023934
- Address
- 300 E Randolph St Ste 40.100
- City
- Chicago
- State
- IL
- Postal Code
- 60601
- Country
- US
- Correspondent
- Ashish Patel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2016-02-03 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2025-11-26 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2012-02-01 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2023-03-23 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2018-05-15 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2015-11-12 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2016-02-03 |
Proprietary Names
Typesafe 2 Segment Piercing Device
TypeSafe Segment Sampling Device
Sterile Label Kit
SmearSafe
CultureSafe
Drain Glider
Universal Tube, Universal Cap
Convenience Bag
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device