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
Backflush instrument with diathermy, incl. active aspiration. (23 gauge / 0.6 mm	1281.D206	FDA UDI	Class II	Active
EVA Custom TDC Vitrectomy Pack VGPC Input 25G	8525.406	FDA UDI	Class II	Unknown
2.4 mm Disposable phaco set with 30° angled flared needle Note: Incition size 2.	8430.24AF1	FDA UDI	Class II	Active
Disposable Backflush instrument, with brush needle and active aspiration.	1281.BTD	FDA UDI	Class I	Active
DMEK Graft Manipulation Forceps with extra fine tips	50.2203	FDA UDI	Class I	Active
Microforceps: High Myopic Eckardt End-gripping. (23 gauge / 0.6 mm)	1286.WH06	FDA UDI	Class I	Active
Stepped Laserprobe, with Alcon connector. (23 gauge / 0.6 mm)	7511.ALC	FDA UDI	Class II	Active
Replacement tubing for VFI for 1272.SA/SB/SC, 50 cm.	1279.R	FDA UDI	Class I	Active
Bimanual irrigation/aspiration set.(20 gauge / 0.9 mm)	1270.B	FDA UDI	Class II	Active
EVA NEXUS™ Posterior 23G TDC Pack	9311.23G01	FDA UDI	Class II	Active
Scleral Buckling Products: Style 508G, 4.0mm x 12.0mm Grooved Sponge	92-50-40G	FDA UDI	Class II	Active
Scleral Buckling Products: Style 225, 2.5mm Grooved Strip	92-08	FDA UDI	Class II	Active
Backflush instrument with active aspiration 20G / 0.9 mm.	1281.T	FDA UDI	Class I	Active
Endo-diathermy handle, straight pointed tip.(27 gauge / 0.4 mm)	1120.04	FDA UDI	Class II	Active
Disposable EVA Drapes	8110.DRA01	FDA UDI	Class II	Active
EVA NEXUSTM Custom Phaco Pack 2.2mm 30 (Angled)	9530.22AF1	FDA UDI	Class II	Active
Backflush Needle with tapered tip from 23 gauge/0.6 mm to 27 gauge/0.4 mm	1281.CD27	FDA UDI	Class I	Active
2.8 mm Triple step angled flared phaco needle with 45 degrees tip. (disposable)	8400.28A02	EUDAMEDFDA UDI	Class II	Active
EVA TDC Vitrectomy Pack Gravity Input 23G	8310.23G11	FDA UDI	Class II	Active
Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)	7223.DORC	FDA UDI	Class II	Active
EVA NEXUS™ cartridge with 0, 5 L collection bag	9100.CAR01-00	FDA UDI	Class II	Active
2.8 mm Triple step angled flared phaco needle. (disposable)	8400.28A01	FDA UDI	Class II	Active
Eckardt Membrane Pic.(23 gauge / 0.6 mm)	1292.E06	EUDAMEDFDA UDI	Class I	Active
Custom Tdc Vitrec.pack Vgp 25g	8525.406-00	FDA UDI	Class II	Unknown
Shielded TotalView Endoillumination Probe incl illuminated scleral depressor 25G	3269.SBS05	FDA UDI	Class II	Active
EVA NEXUS™ Irrigation and Aux. Aspiration Tubing	9110.IAD01	FDA UDI	Class II	Active
EVA NEXUSTM Custom Phaco Pack 1.8mm 30 (Angled)	9530.18AF1	FDA UDI	Class II	Active
Disposable frosted scleral depressor	2013-033	FDA UDI	Class II	Active
Disposable Microforceps: Asymmetrical endgripping.(25 gauge / 0.5 mm)	2286.KD05	FDA UDI	Class I	Active
Microforceps: ILM.(25 gauge / 0.5 mm)	1286.ILM05	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack Gravity Input 25G	8310.25G11	FDA UDI	Class II	Active
2.2 mm Reusable phaco set with 30° straight flared needle	3430.22SF1	EUDAMEDFDA UDI	Class II	Active
Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)	7225.DORC	FDA UDI	Class II	Active
2.2 mm Disposable phaco set with 45° straight flared needle	8445.22SF1	FDA UDI	Class II	Active
Slit Knife, 2.75mm, angled 45°, bibevel	51.3727	FDA UDI	Class I	Active
EVA TDC Vitrectomy Pack VGPC Input 27G	8310.27G12-00	FDA UDI	Class II	Active
EVA NEXUS™ Infusion Giving Set	9110.INP01-00	FDA UDI	Class II	Active
Eftiar Dual Bore Cannula.(23 gauge / 0.6 mm)	EFD.06	FDA UDI	Class I	Active
2.8 mm Reusable phaco set with 30° straight flared needle	3430.28SF1	EUDAMEDFDA UDI	Class II	Active
Disposable EVA Irrigation and Aspiration Tubing	8110.IAD01	FDA UDI	Class II	Active
Safety filter for Leica Microscopes, Passive	8005.F4	FDA UDI	Class II	Active
Disposable EVA Collection Bag 0.5 L	8110.BAG01	EUDAMEDFDA UDI	Class II	Active
2.2 mm Reusable phaco set with 45° straight flared needle	3445.22SF1	FDA UDI	Class II	Active
23-gauge soft tipped cannulas	1272.SD23	EUDAMEDFDA UDI	Class I	Active
Scleral Buckling Products: Style 289, Convex Tire	92-24	FDA UDI	Class II	Active
Disposable Backflush instrument, with brush needle and passive aspiration.	1281.BD	FDA UDI	Class I	Active
Spaide soft-tipped diamond dusted cannula. (23 gauge/0.6mm)	1272.SDT23	FDA UDI	Class I	Active
Scleral Buckling Products: Style 40, 2.0mm Circling Band	92-01	FDA UDI	Class II	Active
Extendible 41 G subretinal injection needle. (23 gauge / 0.6 mm)	1270.EXT	FDA UDI	Class I	Active
Disposable EVA VGPC Input Set	8110.VGP01-00	FDA UDI	Class II	Active

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