FDA Registration
Active
🇺🇸 United States
OTE' NORTH AMERICA LLC.
Reg #: 3007392179
·
FEI: 3007392179
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OTE' NORTH AMERICA LLC.
- Registration Number
- 3007392179
- FEI Number
- 3007392179
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 265 E MERRICK RD, STE 208
- City
- Valley Stream
- State
- NY
- ZIP
- 11580
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210051
Owner / Operator
- Firm Name
- Ote' North America LLC.
- Operator Number
- 10028635
- Address
- 381 Pearsall Ave
- City
- Cedarhurst
- State
- NY
- Postal Code
- 11516
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2021-10-06 |
Establishment Types
Repack or Relabel Medical Device