FDA Registration
Active
🇳🇱 Netherlands
Single Trocar
Reg #: 9611516
·
FEI: 3002806863
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Registration Number
- 9611516
- FEI Number
- 3002806863
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SCHEIJDELVEWEG 2
- City
- ZUIDLAND Zuid-Holland
- Country
- NL
Owner / Operator
- Firm Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.
- Operator Number
- 8030460
- Address
- SCHEIJDELVEWEG 2, --
- City
- ZUIDLAND
- State
- Zuid-Holland
- Postal Code
- 3214 VN
- Country
- NL
- Correspondent
- Michel - van der Schans
US Agent
- Business Name
- Dutch Ophthalmic USA
- Contact Name
- Deborah Thibodeaux
- Address
- 10 Continental Drive, Bldg 1
- City
- Exeter
- State
- NH
- ZIP
- 03833
- Country
- US
- [email protected]
- Phone
- 603 7786929 ext. 170
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2005-01-06 |
Proprietary Names
Single Trocar
Two Step Cannula set with High Flow infusion line.
Cannula set with High Flow infusion line.
27G Ultra Short Disposable One-Step cannula system
Reusable Two step cannula system
Disposable Hybrid Trocar System
High Flow infusion line
Disposable Universal silicone infusion line for cannula system.
Disposable one step single cannula including inserter
One step stiletto insertor
Disposable One step Cannula System
Reusable universal cannula
Closure valves for cannula system.
Disposable Two step vitrectomy system
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device