FDA Registration
Active
🇺🇸 United States
BIOMED LABORATORIES LLC
Reg #: 3006784948
·
FEI: 3006784948
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- BIOMED LABORATORIES LLC
- Registration Number
- 3006784948
- FEI Number
- 3006784948
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8181 Eastpoint Drive
- City
- Dallas
- State
- TX
- ZIP
- 75227
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100613
Owner / Operator
- Firm Name
- BIOMED LABORATORIES LLC
- Operator Number
- 9103441
- Address
- 8181 Eastpoint Drive
- City
- Dallas
- State
- TX
- Postal Code
- 75227
- Country
- US
- Correspondent
- Jason Troutman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-10-01 |
| Wound Dressings Containing Topical Analgesics | SEJ | Class U | Unknown | No | 2016-11-09 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2010-11-17 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2018-07-24 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-07-09 |
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 2007-07-26 |
Proprietary Names
BIAKOS Antimicrobial Skin & Wound Cleanser
Rochal BIAKOS Antimicrobial Wound Gel
Vashe Wound Solution OTC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device