FDA Registration
Active
🇺🇸 United States
EQUASHIELD LLC
Reg #: 3008434487
·
FEI: 3008434487
·
Expires 2026
Products
2
Proprietary Names
4
Establishment Types
2
Classifications
2
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Registration Details
- Registration Name
- EQUASHIELD LLC
- Registration Number
- 3008434487
- FEI Number
- 3008434487
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2 Harbor Park Drive
- City
- Port Washington
- State
- NY
- ZIP
- 11050
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170706
Owner / Operator
- Firm Name
- EQUASHIELD LLC
- Operator Number
- 10041242
- Address
- 2 Harbor Park Drive
- City
- Port Washington
- State
- NY
- Postal Code
- 11050
- Country
- US
- Correspondent
- Michal Levy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-06-17 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2017-12-03 |
Proprietary Names
Sampling Kit Syringe
CellSHIELD®
Equashield Reconstitution Set
CSTD
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device