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 509, 3.5mm x 7.5mm Oblong Sponge	92-50-35	FDA UDI	Class II	Active
Replacement backflush Needle, straight.(23 gauge / 0.6 mm)	1281.A506	FDA UDI	Class I	Active
Cryo Probe: Extended Retinal, 2.5mm	1540.D	FDA UDI	Class II	Active
High Flow Viscous Fluid Extraction Suitable for 20/23/25/27G DORC Cannula System	1362.VFE	FDA UDI	Class I	Active
Irrigation sleeve for 1.8 mm phaco needle.	3008.IR18	FDA UDI	Class II	Active
27G Single Trocar	1272.EDPP27-00	FDA UDI	Class I	Active
Micro Capsulorhexis forceps intraocular style.(23 gauge / 0.6 mm)	50.265	FDA UDI	Class I	Active
Phaco emulsification handpiece.	3002	FDA UDI	Class II	Active
Shielded TotalView Endoillumination Probe, including illuminated scleral depress	3269.SBS04-00	FDA UDI	Class II	Active
Disposable EVA VGPC Input Set	8110.VGP01	EUDAMEDFDA UDI	Class II	Active
Replacement backflush reservoir with active aspiration.	1281.XD	FDA UDI	Class I	Active
Disposable Dual bore BSS injection needle.(41 gauge / 0.1 mm)	1270.01	FDA UDI	Class I	Active
Backflush Instrument with 27 Ga / 0.4 mm brush needle and active aspiration	2281.BTD04	FDA UDI	Class I	Active
2.8 mm Reusable phaco set with 45° angled flared needle Note: Maximum 20x reusab	3445.28AF1	FDA UDI	Class II	Active
23G Single Trocar	1272.EDPP23	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack VGPC Input 23G	8310.23G12	FDA UDI	Class II	Active
27G High Flow infusion line	1279.HF27-00	FDA UDI	Class I	Active
Disposable pack for viscous fluid extraction.	1362.D	FDA UDI	Class I	Active
WideView Vitrectomy Lens: 20° Prism	1284.HW	FDA UDI	Class II	Active
WideView Vitrectomy Lens: Flat	1284.DW	FDA UDI	Class II	Active
Closure valves for 23 gauge/0.6 mm vitrectomy system.	1272.ERPP6	FDA UDI	Class I	Active
EVA, combined machine	8000.COM01	FDA UDI	Class II	Active
Disposable infusion sleeve for 2.2 mm phaco needle Including test chamber	3008.IRD22	FDA UDI	Class II	Active
Disposable viscous fluid injection / extraction cannula with 7 mm thin wall poly	1272.VFI20	FDA UDI	Class I	Active
Disposable High Speed Vitrectomy Prof-Pack for Associate (20 gauge / 0.9 mm)	4210.ASC25	FDA UDI	Class II	Active
EVA NEXUS™ Posterior 23G TDC Pack	9311.23G01-00	FDA UDI	Class II	Active
Disposable VFI Cannula, with 7mm thin wall polyimide tip.(25 gauge / 0.5 mm)	1272.VFI05	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack VGPC Input 25G	8310.25G12	FDA UDI	Class II	Active
Associate Cartridge with upgraded infusion line / drip chamber. Suitable for ant	6279.ASC	FDA UDI	Class II	Active
EVA NEXUS™ Infusion Giving Set	9110.INP01	FDA UDI	Class II	Active
Disposable Viscous Fluid Extraction cannula with 14 mm thin wall polyimide tip	1272.VFE20	FDA UDI	Class I	Active
Laser Probe, straight, with DORC connector 25 gauge / 0.5mm	7025.DORC	FDA UDI	Class II	Active
23G/27G Cannula set with 27G High Flow Infusion Line	1272.EDH23	EUDAMEDFDA UDI	Class I	Active
EVA Vitrectomy Pack VGPC Input 25G	8300.25G12	FDA UDI	Class II	Active
27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan	3269.BE27	FDA UDI	Class II	Active
Sauter Hydrodissector (Curved) 27g x 7/8” (0.4 x 22mm)	52.5099	FDA UDI	Class I	Active
Disposable Microforceps: Eckardt End-gripping.(27 gauge / 0.4 mm)	1286.WD04	FDA UDI	Class I	Active
Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9	3269.D	FDA UDI	Class II	Active
Scleral Buckling Products: Style 506G, 3.0mm x 5.0mm Grooved Sponge	92-50-3G	FDA UDI	Class II	Active
TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga	3269.B	FDA UDI	Class II	Active
Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth	1285.2	FDA UDI	Class II	Unknown
Collection bag for Associate REF: 6279.ASD1 Cartridge.	6279.ASD4	FDA UDI	Class I	Active
Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max.	1267.NMD05	FDA UDI	Class II	Active
Disposable EVA Air Fluid Dual Tubing	8110.AFD01	FDA UDI	Class II	Active
23G Two Step Cannula set with High Flow infusion line	1272.ED223	FDA UDI	Class I	Active
Disposable Backflush instrument, with blunt needle and active aspiration.(25 gau	1281.AD05	FDA UDI	Class I	Active
EVA Vitrectomy Pack VGPC Input 25G	8300.25G12	FDA UDI	Class II	Active
Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge	3269.PD27-00	FDA UDI	Class II	Active
LASIK Irrigating Cannula, 2 Ports 2, 4, + 6mm from tip 25g x 7/8” (0.5 x 22mm)	52.5250	FDA UDI	Class I	Active
Microforceps: Eckardt End-gripping.(23 gauge / 0.6 mm)	1286.W06	FDA UDI	Class I	Active

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