FDA Registration
Active
🇺🇸 United States
Atlas Healthcare LLC
Reg #: 3029802606
·
FEI: 3029802606
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Atlas Healthcare LLC
- Registration Number
- 3029802606
- FEI Number
- 3029802606
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 411 Ne 52nd St
- City
- Miami
- State
- FL
- ZIP
- 33137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241036
Owner / Operator
- Firm Name
- Atlas Healthcare LLC
- Operator Number
- 10089018
- Address
- 2232 Dell Range Blvd, Ste 245-3569
- City
- Cheyenne
- State
- WY
- Postal Code
- 82009
- Country
- US
- Correspondent
- Adam Rosenbloom
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2025-08-03 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2025-08-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-08-03 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-08-03 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2025-08-03 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-08-03 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2025-08-03 |
Proprietary Names
SomaGuard Autoclave Indicator Tape
SomaGuard Patient Bibs
SomaGuard Surgical Face Masks
SomaGuard Self-Sealing Sterilization Pouches
SomaGuard Disposable Isolation Gowns
SomaGuard Self-Adhesive Barrier Film
SomaGuard Disposable Bouffant Caps
SomaGuard Disposable Surgical Caps
Establishment Types
Repack or Relabel Medical Device