FDA Registration
Active
🇺🇸 United States
MERET USA LLC
Reg #: 3021841055
·
FEI: 3021841055
·
Expires 2026
Products
15
Proprietary Names
1
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- MERET USA LLC
- Registration Number
- 3021841055
- FEI Number
- 3021841055
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 151 SHIPYARD WAY, SUITE B
- City
- Newport Beach
- State
- CA
- ZIP
- 92663
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233598
Owner / Operator
- Firm Name
- MERET USA LLC
- Operator Number
- 10084520
- Address
- 3406 VIA LIDO STE. 1A #31
- City
- Newport Beach
- State
- CA
- Postal Code
- 92663
- Country
- US
- Correspondent
- SCOTT M DECKER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2024-10-24 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-10-28 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-10-24 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-24 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-10-24 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-24 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2022-03-04 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-10-24 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-10-24 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-10-24 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2024-10-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-10-24 |
Proprietary Names
MERET
Establishment Types
Repack or Relabel Medical Device