Question 1

What types of medical devices does Dutch Ophthalmic Research Center International BV manufacture?

Accepted Answer

Dutch Ophthalmic Research Center International BV specializes in ophthalmic surgical systems. Their product range includes vitrectomy platforms like the ASSOCIATE 2500 series, disposable cryo probes for retinal detachment procedures, and anterior segment machines such as the EVA series. They also produce combined vitrectomy and anterior segment systems with optional laser integration, as well as high-intensity illumination systems like the XENON BRIGHTSTAR. These devices are designed for use in eye surgeries, including vitreoretinal and anterior segment procedures.

Question 2

Where is Dutch Ophthalmic Research Center International BV based?

Accepted Answer

The company is based in the United States. While the name includes 'International,' the operational headquarters and manufacturing are located within the US.

Question 3

Which regulatory registries or databases list devices manufactured by Dutch Ophthalmic Research Center International BV?

Accepted Answer

Devices from Dutch Ophthalmic Research Center International BV are listed in the FDA’s 510(k) clearance registry. This registry tracks Class II medical devices that have undergone the 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device.

Question 4

How are the devices manufactured by Dutch Ophthalmic Research Center International BV classified under FDA regulations?

Accepted Answer

All devices produced by Dutch Ophthalmic Research Center International BV fall under Class II classification according to FDA regulations. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, and they must undergo the 510(k) clearance process to demonstrate compliance with these requirements.

Question 5

Why are the company’s devices listed under the 510(k) clearance process?

Accepted Answer

The company’s devices are listed under the 510(k) clearance process because they are classified as Class II under FDA regulations. This classification means they pose moderate risk and require additional controls beyond general regulatory requirements. The 510(k) process ensures that each device is substantially equivalent to a legally marketed predicate device, confirming that it meets the same performance standards and safety expectations.

Device	Model / Reference	Registries	Class	Status
Microforceps: Horizontal Subretinal, 3 mm.(20 gauge / 0.9 mm)	1286.O	FDA UDI	Class I	Active
2.5 mm Straight phaco needle. (disposable)	8400.25S01	FDA UDI	Class II	Active
MICS 1.8 mm Disposable phaco set with 45° straight flared needle	8445.18SF1	FDA UDI	Class II	Active
EVA TDC Vitrectomy Pack Gravity Input 27G	8310.27G01	FDA UDI	Class II	Active
Scleral Buckling Products: Style 501, 2.5mm x 4.0mm Oval Sponge	92-50-4	FDA UDI	Class II	Active
Anterior Chamber Cannula – Rycroft 21g x 7/8” (0.81 x 22mm)	52.1281	FDA UDI	Class I	Active
Disposable Microforceps: ILM.(20 gauge / 0.9 mm)	1286.ILMD	FDA UDI	Class I	Active
Disposable Chandelier fiber (one fiber) with Photon connector and guidance needl	3269.P27-00	FDA UDI	Class II	Active
Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio	7510.DORC	FDA UDI	Class II	Active
Microscissors: Vertical.(20 gauge / 0.9 mm)	1286.E	FDA UDI	Class I	Active
EVA Custom Vitrectomy Pack VGPC 23G	8523.211	FDA UDI	Class II	Active
Microforceps: Serrated Jaws.(23 gauge / 0.6 mm)	1286.C06	FDA UDI	Class I	Active
EVA Custom TDC Vitrectomy Pack VGPC Input 27G	8527.402	FDA UDI	Class II	Active
Illuminated Curved Laser probe, 25 gauge / 0, 5mm with Alcon connector	7625.ALC	FDA UDI	Class II	Active
Blue infusion sleeve for 3004.FD & 3006.PF phaco needles	3003	FDA UDI	Class II	Active
Spaide TotalView Endoillumination Probe, including illuminated scleral depressor	3269.SB06-00	FDA UDI	Class II	Active
Scleral Buckling Products: Style N/A, 5.0mm Silicone Strip	92-29	FDA UDI	Class II	Active
Spare bulb for REF: 1266.XIII Xenon BrightStar illumination System.	1266.XD	FDA UDI	Class II	Active
Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4	3269.D04-00	FDA UDI	Class II	Active
Large replacement backflush Reservoir for 1281.C.	1281.C1	FDA UDI	Class I	Active
Illuminated Laser Probe, Curved, 20G / 0.9 mm	7410.DORC	FDA UDI	Class II	Active
Reusable phaco needle wrench for 3004.FD, 3005.FDS & 3005.FT	3004.W	FDA UDI	Class II	Active
EVA Nexus™ Irrigation Tubing	9110.IRR01	EUDAMEDFDA UDI	Class II	Active
Cystotome (Short Curve) Formed Irr. Capsularhexis 27g x 5/8” (0.4 x 16mm)	52.5042	FDA UDI	Class I	Active
Diathermy cable, for 1120 / 1121 / 1122 / 1120-0.5 / 1120-D-0.5 and 1120-0.6 han	1120.A	FDA UDI	Class II	Active
EVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Straight)	9545.18SF1	FDA UDI	Class II	Active
Disposable Drapes, for Associate touch screen & remote control.	6279.SD	FDA UDI	Class II	Active
Akgül Biopsy Forceps with sharp tip. (23 gauge / 0.6 mm)	1286.ABF	FDA UDI	Class I	Active
926823G Two Dimensional Cutter – 20k CPM	9268.VIT23-00	FDA UDI	Class II	Active
Universal PVC infusion line for 23G cannula system for VFI/VFE	1279.VFI	FDA UDI	Class II	Active
Disposable infusion sleeve for 2.8 mm phaco needle including test chamber.	3009.IRD28	FDA UDI	Class II	Active
27G High Flow infusion line	1279.HF27	FDA UDI	Class I	Active
EVA NEXUS™ cartridge with 0, 5 L collection bag	9100.CAR01	EUDAMEDFDA UDI	Class II	Active
Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm)	7227.ALC	FDA UDI	Class II	Active
Extendible brush backflush instrument with active aspiration. (23 gauge / 0.6 mm	1290.BTD23	FDA UDI	Class I	Active
23G Two Step Cannula set with High Flow infusion line	1272.ED223-00	FDA UDI	Class I	Active
Sterilization tray for 1 Micro-forceps/scissors.	1286.SS	FDA UDI	Class I	Active
EVA NEXUS™ Digital Overlay System	9000.DOS01	FDA UDI	Class II	Active
EVA Custom TDC Vitrectomy Pack VGPC Input 23G	8523.422	FDA UDI	Class II	Active
27G Ultra Short Vitrectomy Kit	8310.27KS	EUDAMEDFDA UDI	Class II	Active
Subretinal cannula, curved 20 gauge/0.9 mm needle with 0.3 mm tip.	1295.3	FDA UDI	Class I	Active
Scleral Buckling Products: Style 503, 3.0mm Round Sponge	92-50-3R	FDA UDI	Class II	Active
P.L.K. Scraper, style II.	50.2119	FDA UDI	Class I	Active
Scleral Buckling Products: Style 286, Convex Tire	92-22	FDA UDI	Class II	Active
Microscissors: Curved, Horizontal.(25 gauge / 0.5 mm)	1286.M05	FDA UDI	Class I	Active
Disposable Microforceps: Extended reach – Wide grip, 27 gauge / 0.4 mm	1286.WRD04	FDA UDI	Class I	Active
Microforceps: Shah Micro Serrated Jaws.(25 gauge / 0.5 mm)	1286.C305	EUDAMEDFDA UDI	Class I	Active
2.2 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab	3445.22AF1	FDA UDI	Class II	Active
23G Cannula set with High Flow infusion line	1272.ED23-00	FDA UDI	Class I	Active
MVR Blade 20G, angled	52.5220	FDA UDI	Class I	Active

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