FDA Registration
Active
🇳🇱 Netherlands
Endo-diathermy handle, straight pointed tip.
Reg #: 9611516
·
FEI: 3002806863
·
Expires 2025
Products
3
Proprietary Names
75
Establishment Types
2
Classifications
3
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
Regulatory Submissions
- 510(k) Number
- K190875
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
Proprietary Names
Endo-diathermy handle, straight pointed tip.
Disposable phaco set with 45 angled flared needle
Shielded TotalView Endoillumination Probe, including illuminated scleral depressor
27G Ultra Short Disposable 8000 CPM TDC cutter
Diathermy cable
Disposable phaco set with 45 straight flared needle
Curved tip for universal I/A handpiece
TotalView Endoillumination Probe, including illuminated scleral depressor
Disposable EVA VGPC Input Set
Straight phaco needle
EVA Cartridge with 0.5 L Collection Bag
Universal PVC infusion line for 23G cannula system for VFI/VFE
Reusable phaco sleeve
Disposable EVA Irrigation and Aspiration Tubing
Triple step flared phaco needle
Safety filter for Leica Microscopes, Passive
EVA Flight Case
Disposable phaco fragmentation needle, incl. wrench
Exo diathermy handle with 45 curved tip, diameter 1.3 mm.
Phaco Sure Touch Handpiece
Safety filter for Leica Microscopes, Manual
EVA Mayo Arm
Disposable phaco set with 30 angled flared needle
Disposable tubings complete with filter for air-fluid exchange
Straight tip for universal I/A handpiece
Cleaning adaptor for phaco sleeve
Universal I/A handpiece, excl. tips
Cleaning adapter for phaco needle
Irrigation sleeve for phaco needle.
Reusable phaco set with 45 straight flared needle
Disposable EVA Air Fluid Dual Tubing
EVA, combined machine including Laser (DORC connector)
Disposable EVA Double Irrigation Line with Air Exchange
Triple step angled flared phaco needle. (disposable)
Endoillumination Probe, including illuminated scleral depressor
Disposable High Speed Cutter
VFI Pack for Silicone Oil syringes
Disposable infusion sleeve
Disposable EVA Gravity Input Set
Reusable phaco set with 30 angled flared needle
Two Dimensional Cutter 16k CPM
EVA Custom TDC Vitrectomy Pack VGPC Input
Disposable test chamber for phaco handpiece
Reusable phaco set with 45 angled flared needle
Disposable EVA Accessory Set
Bimanual irrigation/aspiration set
Endo-diathermy handle, straight pointed tip.(20 gauge / 0.9 mm)
Featherlight micro Phaco emulsification/fragmentation handpiece.
Reusable phaco set with 30 straight flared needle
EVA Vitrectomy Pack Gravity Input
27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depressor
Disposable High Speed TDC Cutter DORC Continuum range
EVA Vitrectomy Pack VGPC Input
EVA Dust Cover
Straight phaco needle. (disposable)
EVA TDC Vitrectomy Pack Gravity Input
Disposable infusion sleeve phaco needle including test chamber
EVA, anterior machine
Disposable EVA Collection Bag 0.5 L
EVA TDC Vitrectomy Pack VGPC Input
Bipolar Coagulation Forceps, 12 cm, angled, excl. cable
Disposable frosted scleral depressor
Test chamber for phaco handpiece
Safety filter for Zeis/Moeller-Wedel Microscopes, Manual
Disposable phaco set with 30 straight flared needle
Phaco emulsification handpiece.
Triple step angled flared phaco needle
Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive
Universal metal wrench for star phaco needles
EVA, combined machine
Disposable EVA Closure Plug Aspiration
EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short
EVA, combined machine including Laser (SMA connector)
Disposable EVA Drapes
Triple step flared phaco needle. (disposable)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device