Question 1

What types of medical devices does Psi/Eye-Ko, Inc. manufacture?

Accepted Answer

Psi/Eye-Ko, Inc. specializes in ophthalmic surgical instruments. Their product range includes cannulas for corneal procedures like LASIK, infusion cannulas for intraocular applications, vitreoretinal micropicks for retinal surgery, peribulbar needles for regional anesthesia, irrigating cystotomes for cataract surgery, capsule polishers for lens cleaning, and sub-Tenon cannulas for periocular injections. These devices are designed for precision in eye surgeries.

Question 2

Where is Psi/Eye-Ko, Inc. based, and how does this affect their devices?

Accepted Answer

Psi/Eye-Ko, Inc. is based in the United States. While their headquarters are in the US, their devices are engineered to comply with international regulatory standards, particularly those relevant to ophthalmic surgical instruments. This ensures their products meet the requirements of markets where they are distributed, including the EU.

Question 3

Which regulatory registries list Psi/Eye-Ko, Inc.’s devices?

Accepted Answer

Psi/Eye-Ko, Inc.’s devices are listed in the eudamed registry, which is the European database for medical devices. This registry is used to track devices that have been authorized for placement on the EU market, ensuring transparency and traceability for healthcare professionals and regulators.

Question 4

How are Psi/Eye-Ko, Inc.’s devices classified under EU regulations?

Accepted Answer

Psi/Eye-Ko, Inc.’s devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices. This classification applies to instruments that pose a moderate risk to patients, such as certain surgical tools used in ophthalmology. Class IIa devices require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations and risk management processes.

Device	Model / Reference	Registries	Class	Status
Anterior Chamber Cannula 19g X 4mm bend	1008-4	EUDAMED	Class IIa	Active
Anterior Chamber Cannula 21g X 22mm (7/8"), straight	1106S	EUDAMED	Class IIa	Active
Anterior Chamber Cannula Thin Wall 23g X 3mm bend	2004-3	EUDAMED	Class IIa	Active
Hydrodelineation Cannula [Kellan] 27g X 22mm (7/8"), curved	7011	EUDAMED	Class IIa	Active
[Chang] Hydrodissection Cannula 27g	7018	EUDAMED	Class IIa	Active
Chamber Maintainer 20g w/ serrated tip	9006	EUDAMED	Class IIa	Active
[Linn] Lasik Cannula 25g	9903-9	EUDAMED	Class IIa	Active
Irrigating Vectis 24g, 2 port, 4mm width	7002	EUDAMED	Class IIa	Active
Lasik Cannula 25g X 22mm (7/8”), formed 7mm	9903-7F	EUDAMED	Class IIa	Active
Olive Tip Capsule Polisher 23g X 10mm bend, sandblasted end	8503	EUDAMED	Class IIa	Active
Irrigating Cystotome 23g X 19mm (3/4"), formed	5004BF	EUDAMED	Class IIa	Active
Flute Needle [Charles] 25g X 25mm (1")	9025-25	EUDAMED	Class IIa	Active
[Vidaurri] Lasik Cannula 25g	9903V	EUDAMED	Class IIa	Active
Chamber Maintainer 25g w/ serrated tip	9004	EUDAMED	Class IIa	Active
Viscoelastic Cannula 27G, formed, thin wall	2200	EUDAMED	Class IIa	Active
Irrigating Cystotome 25g X 16mm (5/8"), formed	5003AFA	EUDAMED	Class IIa	Active
Irrigating Cystotome 30g X 16mm (5/8"), straight	5000AS	EUDAMED	Class IIa	Active
Anterior Chamber Cannula 19g X 8mm bend	1008-8	EUDAMED	Class IIa	Active
Anterior Chamber Cannula Thin Wall 23g X 11mm bend	2004-11	EUDAMED	Class IIa	Active
25g Cannula Cortex	3008	EUDAMED	Class IIa	Active
[Perone] Lasik Cannula 25g, right	9903-PR	EUDAMED	Class IIa	Active
Anterior Chamber Cannula 21g X 6mm bend	1006-6	EUDAMED	Class IIa	Active
Capsule Polisher 23g, side port	6001	EUDAMED	Class IIa	Active
Vitreoretinal Micropick [Glaser] 23g, tapered to 27g, straight	9031S	EUDAMED	Class IIa	Active
Peribulbar Needle [Atkinson] 25g X 22mm (7/8")	0003C	EUDAMED	Class IIa	Active
Soft Tip Cannula 20g X 3mm tip	9607-3	EUDAMED	Class IIa	Active
Subretinal Cannula [Lambert] 20g tapered to 33g, curved	9036	EUDAMED	Class IIa	Active
[Kratz] wire speculum, open blades	8404	EUDAMED	Class IIa	Active
Anodyne Surgical	7013	FDA UDI	Class I	Active
Anodyne Surgical	1000-12	FDA UDI	Class I	Active
Anodyne Surgical	2103C	FDA UDI	Class I	Active
Anodyne Surgical	1000-4.1	FDA UDI	Class I	Active
Anodyne Surgical	9903-9F	FDA UDI	Class I	Active
Anodyne Surgical	0004H	FDA UDI	Class I	Active
Anodyne Surgical	6004	FDA UDI	Class I	Active
Anodyne Surgical	1100S	FDA UDI	Class I	Active
Anodyne Surgical	1106C	EUDAMEDFDA UDI	Class I	Active
Anodyne Surgical	8603	FDA UDI	Class I	Active
Anodyne Surgical	5003AC	FDA UDI	Class I	Active
Anodyne Surgical	5001AC	FDA UDI	Class I	Active
Anodyne Surgical	0001C	FDA UDI	Class I	Active
Anodyne Surgical	7004.2	FDA UDI	Class I	Active
Anodyne Surgical	7020	EUDAMEDFDA UDI	Class I	Active
Anodyne Surgical	8203	EUDAMEDFDA UDI	Class I	Active
Anodyne Surgical	5001AS	FDA UDI	Class I	Active
Anodyne Surgical	AE02-2404-4506	FDA UDI	Class I	Active
Anodyne Surgical	7005.2	FDA UDI	Class I	Active
Anodyne Surgical	4003	FDA UDI	Class I	Active
Anodyne Surgical	1004-4	FDA UDI	Class I	Active
Anodyne Surgical	9011SB	EUDAMEDFDA UDI	Class I	Active

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