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
EVA NEXUSTM Custom Phaco Pack 2.2mm 45 (Angled)	9545.22AF1	FDA UDI	Class II	Active
Touch screen pen. Accessory to the DORC Associate	6279.PEN	FDA UDI	Class II	Active
Disposable One Step Cannula System (25 gauge/0.5 mm)	1272.ED205	FDA UDI	Class I	Active
Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo	1279.IA20S	FDA UDI	Class I	Active
Scleral Buckling Products: Style 270, Silicone Sleeve	92-14	FDA UDI	Class II	Active
20GA Straight Laser Probe with Alcon adaptor	7011.ALC	FDA UDI	Class II	Active
EVA Vitrectomy Pack Gravity Input 25G	8300.25G11	FDA UDI	Class II	Active
Disposable I/A silicone replacement Tubing set for REF: 6279.ASD1 Cartridge, inc	6279.ASD2S	FDA UDI	Class II	Active
DMEK Sinskey Hook Down	50.2202	FDA UDI	Class I	Active
Disposable Microforceps: End-gripping.(20 gauge / 0.9 mm)	1286.BD	FDA UDI	Class I	Active
25G High Flow infusion line	1279.HF25	FDA UDI	Class I	Active
EVA NEXUS™ Combined 25G TDC Pack	9310.25G02	FDA UDI	Class II	Active
Scleral Buckling Product Style 505T, 5.0mm Round Tunel Sponge	92-50-32G	FDA UDI	Class II	Active
EVA Custom TDC Vitrectomy Pack VGPC Input 23G	8523.210	FDA UDI	Class II	Active
Scleral plug forceps	1277	FDA UDI	Class I	Active
TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga	3269.B06	FDA UDI	Class II	Active
Disposable Microforceps: Power End-gripping. (27 gauge / 0.4 mm)	1286.WPD04	FDA UDI	Class I	Active
Stab Knife, 15°	51.4891	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack VGPC Input 23G	8310.23G12-00	FDA UDI	Class II	Active
Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)	3269.A27-00	FDA UDI	Class II	Active
Replacement Backflush Needle with silicone tip, straight.	1281.BSS	FDA UDI	Class I	Active
Scleral Buckling Products: Style 70, Silicone Sleeve	92-13	FDA UDI	Class II	Active
Disposable Infusion Cannula, 6.0 mm.	1272.BD	FDA UDI	Class I	Active
Scleral Buckling Products: Style 276, Asymmetrical Tire	92-18	FDA UDI	Class II	Active
EVA Vitrectomy Pack Gravity Input 20G	8300.20G11	FDA UDI	Class II	Active
Microscissors: Curved, Horizontal.(23 gauge / 0.6 mm)	1286.M06	EUDAMEDFDA UDI	Class I	Active
EVA, anterior machine	8000.ANT01	FDA UDI	Class II	Active
Disposable High Speed TDC Cutter 25 G / 8000 CPM DORC Continuum range	8268.VIT25-00	FDA UDI	Class II	Active
TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)	3269.EB05	EUDAMEDFDA UDI	Class II	Active
20GA Curved Laser Probe with Alcon adaptor	7010.ALC	FDA UDI	Class II	Active
Disposable Eckardt Membrane Pic.(25 gauge / 0.5 mm)	1292.ED05	FDA UDI	Class I	Active
EVA Nexus™ Infusion and Aux. Aspiration Tubing	9110.IAD02	FDA UDI	Class II	Active
Disposable reversed Sinskey hook with irrigation	50.2210	FDA UDI	Class I	Active
2.2 mm Disposable phaco set with 30° straight flared needle	8430.22SF1	FDA UDI	Class II	Active
WideView Vitrectomy Lens: Biconcave	1284.EW	FDA UDI	Class II	Active
EVA, anterior machine	8000.ANT01	FDA UDI	Class II	Active
Olive Tip Polisher (Curved) Micro etched 23g x 1” (0.6 x 25mm)	52.5143	FDA UDI	Class I	Active
Disposable High Speed TDC Cutter 23 G / 8000 CPM DORC Continuum range	8268.VIT23	FDA UDI	Class II	Active
I/A Handpiece with curved tip.	1273.A	FDA UDI	Class II	Active
EVA, combined machine including Laser (DORC connector)	8000.COM02	FDA UDI	Class II	Active
Irrigation sleeve for 2.8 mm phaco needle.	3008.IR28	FDA UDI	Class II	Active
Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6	3269.D06-00	FDA UDI	Class II	Active
Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max	2267.NMD04	FDA UDI	Class II	Active
EVA Vitrectomy Pack VGPC Input 23G	8300.23G12	FDA UDI	Class II	Active
One step stiletto insertor.(23 gauge / 0.6 mm)	1282.F06	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack Gravity Input 25G	8310.25G11	FDA UDI	Class II	Active
Disposable Backflush instrument, with blunt needle and passive aspiration.(23 ga	1281.AD06	FDA UDI	Class I	Active
Formed Irrigating Cystotome 25g x 5/8” (0.5 x 16mm)	52.1610	FDA UDI	Class I	Active
23G Cannula set with High Flow infusion line	1272.ED23	FDA UDI	Class I	Active
EVA NEXUS™, Phaco vitrectomy system	9000.COMU1	FDA UDI	Class II	Active

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