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
Scleral Buckling Products: Style 517, 3.66mm x 7.5mm Half Oval Sponge	92-55-36	FDA UDI	Class II	Active
Curved tip for universal I/A handpiece 1273.EH	1273.EA	FDA UDI	Class II	Active
23G High Flow infusion line	1279.HF23	FDA UDI	Class I	Active
TotalView Endoillumination Probe with Photon connector, including illuminated sc	7055	FDA UDI	Class II	Active
Disposable one step single cannula including inserter. (27 gauge / 0.4 mm)	1272.EDPP4	EUDAMEDFDA UDI	Class I	Active
25G Single Trocar	1272.EDPP25-00	FDA UDI	Class I	Active
Microforceps: Asymmetrical endgripping.(23 gauge / 0.6 mm)	2286.K06	FDA UDI	Class I	Active
Disposable infusion sleeve for 2.8 mm phaco needle Including test chamber	3008.IRD28	FDA UDI	Class II	Active
Curved tip with silicone sleeve for universal I/A handpiece 1273.EH	1273.EPA	FDA UDI	Class II	Active
Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm	1281.BD27	FDA UDI	Class I	Active
Scleral Buckling Products: Style 511, 2.75mm x 7.5mm Half Oval Sponge	92-55-27	FDA UDI	Class II	Active
Scleral Buckling Products: Style 103, Meridional Implant – 15.0mm	92-25	FDA UDI	Class II	Active
EVA Vitrectomy Pack Gravity Input 23G	8300.23G01	FDA UDI	Class II	Active
2.5 mm Straight phaco needle (limited reusable 20x)	3005.S25	FDA UDI	Class II	Active
TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga	3269.B-00	FDA UDI	Class II	Active
23G Two Dimensional Cutter – 16k CPM	8278.VIT23	FDA UDI	Class II	Active
Backflush Instrument with 27 Ga / 0.4 mm blunt needle and active aspiration	2281.AD04	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack Gravity Input 27G	8310.27G11	FDA UDI	Class II	Active
EVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Angled)	9545.18AF1	EUDAMEDFDA UDI	Class II	Active
Anterior Chamber Cannula – Rycroft 30g x 7/8” (0.3 x 22mm)	52.1273	FDA UDI	Class I	Active
TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm)	3269.EB06	FDA UDI	Class II	Active
Slit Lamp Adapter safety filters. Active safety filter for use in combination wi	7005.F11	FDA UDI	Class II	Active
Cleaning adapter for phaco needle. Accessory to the DORC phaco needle.	3008.N	FDA UDI	Class II	Active
EVA Vitrectomy Pack Gravity Input 23G	8300.23G11	FDA UDI	Class II	Active
EVA NEXUS™ Posterior 25G TDC Pack	9311.25G01-00	FDA UDI	Class II	Active
2.4 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab	3430.24AF1	FDA UDI	Class II	Active
Phaco Sure Touch Handpiece	3002.P	FDA UDI	Class II	Active
Lachrymal Cannula (Curved) 26g x 1, 25" (0.45 x 32mm)	52.1276	FDA UDI	Class I	Active
Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.	1284.DIS	FDA UDI	Class II	Active
Disposable Infusion Cannula, 6.0 mm.	1272.BD	FDA UDI	Class I	Unknown
Disposable EVA Air Fluid Dual Tubing	8110.AFD01-00	FDA UDI	Class II	Active
2.2 mm Straight phaco needle. (disposable)	8400.22S01	FDA UDI	Class II	Active
Transparent infusion sleeve for 3005.FDM phaco needles	3003.M	FDA UDI	Class II	Active
Disposable High Speed Vitrectomy Pack for Associate (23 gauge / 0.6 mm)	4200.ASC06	FDA UDI	Class II	Active
Disposable keratoscope	1420.D	FDA UDI	Class I	Active
Disposable infusion sleeve for 2.4 mm phaco needle including test chamber.	3009.IRD24	EUDAMEDFDA UDI	Class II	Active
Scleral Buckling Products: Style 20, 2.0mm Grooved Strip	92-03	FDA UDI	Class II	Active
Disposable Microforceps: Eckardt End-gripping.(23 gauge / 0.6 mm)	1286.WD06	FDA UDI	Class I	Active
EVA Nexus™ Aux. Aspiration Tubing	9110.AAS01-00	FDA UDI	Class II	Active
EVA Vitrectomy Pack VGPC Input 23G	8300.23G02	FDA UDI	Class II	Unknown
EVA NEXUS™, Phaco vitrectomy system including laser with DORC connector	9000.COMU2	FDA UDI	Class II	Active
Disposable One step cannula system. (23 gauge / 0.6 mm)	1272.GE206	FDA UDI	Class I	Active
Safety filter for Zeis/Moeller-Wedel Microscopes, Manual	8005.F1	FDA UDI	Class II	Active
Disposable Two step Vitrectomy System.(20 gauge / 0.9 mm)	1272.ED09	FDA UDI	Class I	Active
Disposable Microscissors: Straight.(20 gauge / 0.9 mm)	1286.JD	FDA UDI	Class I	Active
Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5	3269.D05-00	FDA UDI	Class II	Active
2.8 mm Reusable phaco set with 45° straight flared needle	3445.28SF1	FDA UDI	Class II	Active
Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)	3269.MBD27	FDA UDI	Class II	Active
Disposable Microforceps: Serrated Jaws.(20 gauge / 0.9 mm)	1286.CD	FDA UDI	Class I	Active
EVA NEXUS™ Posterior 23G TDC Pack	9310.23G01	FDA UDI	Class II	Active

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