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
25G Two Dimensional Cutter – 16k CPM	8278.VIT25	FDA UDI	Class II	Active
TotalView Chandelier for Eckardt cannula system with Photon connector.(23 gauge	7052	FDA UDI	Class II	Active
Disposable Vitrectomy Lens: 30° Prism	1284.ID	EUDAMEDFDA UDI	Class II	Active
2.5 mm Triple step flared phaco needle. (disposable)	8400.25F01	FDA UDI	Class II	Active
Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /	3269.MF06-00	FDA UDI	Class II	Active
Laser Probe, straight, with DORC connector 20 gauge / 0.9mm	7011.DORC	FDA UDI	Class II	Active
2.2 mm Disposable phaco set with 30° angled flared needle Note: Incision size 2.	8430.22AF1	FDA UDI	Class II	Active
Disposable High Speed Cutter 20G/8000CPM	8267.VIT20	FDA UDI	Class II	Active
Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4	3269.D04	FDA UDI	Class II	Active
Disposable Shiraga Triamcinolone backflush instrument.(20 gauge / 0.9 mm)	1281.SD	FDA UDI	Class I	Active
2.4 mm Reusable phaco set with 30° straight flared needle	3430.24SF1	EUDAMEDFDA UDI	Class II	Active
Backflush Instrument with 25 Ga / 0.5 mm blunt needle and active aspiration.	2281.AD05	FDA UDI	Class I	Active
25-gauge soft tipped cannulas	1272.SD25	FDA UDI	Class I	Active
Exo diathermy handle with 45° curved tip, diameter 1.3 mm.	1122	FDA UDI	Class II	Active
Disposable EVA Gravity Input Set	8110.INP01	FDA UDI	Class II	Active
EVA Vitrectomy Pack Gravity Input 27G	8300.27G11	FDA UDI	Class II	Active
Slit Knife, 2.75mm, angled, bevel up	53.3727	FDA UDI	Class I	Active
Scleral Buckling Products: Style 507, 5.5mm x 7.5mm Oval Sponge	92-50-7.5	FDA UDI	Class II	Active
Disposable EVA Double Irrigation Line with Air Exchange	8110.DIL01	FDA UDI	Class II	Active
MICS 1.8 mm Triple step flared phaco needle. (limited reusable 20x)	3005.F18	FDA UDI	Class II	Active
Disposable Microscissors: Curved, Horizontal.(20 gauge / 0.9 mm)	1286.MD	EUDAMEDFDA UDI	Class I	Active
Disposable Shiraga Backflush instrument, with extendible brush tip and active as	1281.SD06	FDA UDI	Class I	Active
Microforceps: Diamond-dusted.(23 gauge / 0.6 mm)	1286.DIA06	FDA UDI	Class I	Active
2.4 mm Disposable phaco set with 30° straight flared needle	8430.24SF1	FDA UDI	Class II	Active
25G High Flow infusion line	1279.HF25-00	FDA UDI	Class I	Active
Disposable High Speed Cutter 23G/8000CPM	8267.VIT23	FDA UDI	Class II	Active
EVA NEXUS™ Combined 27G TDC Pack	9310.27G02	EUDAMEDFDA UDI	Class II	Active
Disposable infusion sleeve for 2.5 mm phaco needle Including test chamber	3008.IRD25	EUDAMEDFDA UDI	Class II	Active
Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max.	1267.NMD25	FDA UDI	Class II	Active
Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)	7223.ALC	EUDAMEDFDA UDI	Class II	Active
Viscoelastic Cannula Angled 45° 23g x 7/8” (0.6 x 22mm)	52.5009	FDA UDI	Class I	Active
Disposable Phaco Pack	3002.P2	FDA UDI	Class II	Unknown
EVA TDC Vitrectomy Pack VGPC Input 23G	8310.23G02	FDA UDI	Class II	Unknown
TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)	3269.EB05-00	FDA UDI	Class II	Active
Disposable Shiraga Backflush instrument, with extendible brush tip and active as	1281.SD05	FDA UDI	Class I	Active
EVA Custom TDC Vitrectomy Pack VGPC Input 27G	8527.406	FDA UDI	Class II	Active
TotalView Endoillumination Probe, with 2 exchangeable tips.(20 gauge / 0.9 mm)	3269.E	FDA UDI	Class II	Active
EVA NEXUS™ Combined 23G TDC Pack	9311.23G02-00	FDA UDI	Class II	Active
D.A.L.K. Spatula Dissection Set	2110	EUDAMEDFDA UDI	Class I	Active
White infusion sleeve for 3005.FDS phaco needles	3003.S	FDA UDI	Class II	Active
27G Ultra Short Disposable 8000 CPM TDC cutter	8268.27S	FDA UDI	Class II	Active
25G Cannula set with High Flow infusion line	1272.ED25-00	FDA UDI	Class I	Active
Microforceps: Eckardt End-gripping.(20 gauge / 0.9 mm)	1286.W	FDA UDI	Class I	Active
Eckardt temporary keratoprosthesis, Ø 7 mm, 2.8 mm depth	1285.1	FDA UDI	Class II	Unknown
Disposable Fluid Giving set for Associate REF: 6279.ASD1 Cartridge incl connecto	6279.ASD3	FDA UDI	Class II	Active
EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short	8310.27S12	FDA UDI	Class II	Active
Disposable Microforceps: Ultra peel 27 gauge / 0.4 mm	2286.CD304	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack VGPC Input 27G	8310.27G02	FDA UDI	Class II	Unknown
EVA Vitrectomy Pack VGPC Input 27G	8300.27G12	FDA UDI	Class II	Active
Featherlight micro Phaco emulsification/fragmentation handpiece.	3002.M	FDA UDI	Class II	Active

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