FDA Registration
Active
🇺🇸 United States
SCOPE HEALTH
Reg #: 3015534928
·
FEI: 3015534928
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- SCOPE HEALTH
- Registration Number
- 3015534928
- FEI Number
- 3015534928
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 79 Madison Avenue
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
Owner / Operator
- Firm Name
- Scope Health
- Operator Number
- 10060447
- Address
- 79 Madison Avenue
- City
- New York
- State
- NY
- Postal Code
- 10016
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2019-05-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-03-03 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-12-06 |
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2026-04-01 |
Proprietary Names
Optase Cooling Mask
ComplEye
Optase Moist Heat Mask
Optase MX2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198