FDA Registration
Active
🇳🇱 Netherlands
Artisan - Artiflex Enclavation Needle
Reg #: 8040449
·
FEI: 3002501070
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OPHTEC BV
- Registration Number
- 8040449
- FEI Number
- 3002501070
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SCHWEITZERLAAN 15
- City
- GRONINGEN
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K030471
Owner / Operator
- Firm Name
- OPHTEC USA
- Operator Number
- 8040449
- Address
- 400 sawgrass corporate pkwy
- City
- Sunrise
- State
- FL
- Postal Code
- 33325
- Country
- US
- Correspondent
- Abraham Farhan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2007-12-05 |
Proprietary Names
Artisan - Artiflex Enclavation Needle
Verisyse - Veriflex Enclavation Needle
Establishment Types
Manufacture Medical Device