Question 1

What types of medical devices does Blink Medical Limited manufacture?

Accepted Answer

Blink Medical Limited specialises in single-use surgical instruments primarily for ophthalmic (eye) and general surgery. Their portfolio includes ophthalmic surgical probes, soft-tissue manipulation forceps (like tweezers), eyelid speculums, general surgical procedure kits, scissors, needle holders, and specialised tools such as the Graefe Strabismus Hook, Lester IOL Manipulator, and various muscle hooks. These devices are designed for precise tasks like suturing, tissue manipulation, and exposure during surgical procedures.

Question 2

Where is Blink Medical Limited based?

Accepted Answer

Blink Medical Limited is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for devices authorised in the U.S. market.

Question 3

Which regulatory registries list Blink Medical Limited’s devices?

Accepted Answer

Blink Medical Limited’s devices are listed in the FDA’s Unique Device Identification (UDI) system. The UDI registry standardises identification for tracking and post-market surveillance, ensuring transparency and compliance for low-risk Class I devices. This system helps healthcare providers, regulators, and patients access critical information about the devices.

Question 4

How are Blink Medical Limited’s devices classified under U.S. regulations?

Accepted Answer

All of Blink Medical Limited’s listed devices fall under Class I classification in the FDA’s UDI system. Class I devices are generally considered the lowest risk, often involving minimal potential harm to users. This classification applies to single-use surgical instruments like forceps, scissors, and speculums, which require less stringent premarket review but still adhere to manufacturing and labelling standards to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Graefe Strabismus Hook	90-5004	FDA UDI	Class I	Active
Manipulator Spatula	41-3004	FDA UDI	Class I	Active
Needle Holder Nieverts 13cm	HR523	FDA UDI	Class I	Active
Needle Holder Kilner 13cm	HR522	FDA UDI	Class I	Active
Speculum Clarkes	31-3004	FDA UDI	Class I	Active
Alexandra Muscle Hook	90-5005	FDA UDI	Class I	Active
Needle Holder Halsey Smooth 13cm	HR521	FDA UDI	Class I	Active
Chopper Seibel	41-4012	FDA UDI	Class I	Active
Paediatric Speculum Angled Temporal	31-3102	FDA UDI	Class I	Active
Forceps Tying 5mm Platform Angled O/L 105mm	11-6015	FDA UDI	Class I	Active
Lester IOL Manipulator	41-1007	FDA UDI	Class I	Active
Manipulator Ayliffe Double Ended	41-9011	FDA UDI	Class I	Active
Forceps Tying Mcpherson 6mm Platform O/L 110mm	10-9008	FDA UDI	Class I	Active
Scissors Curved Strabismus 11cm	HR240	FDA UDI	Class I	Active
Scissors Tenotomy Curved Blunt Tip	21-7006	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata MICS SS ST	11-5050	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata, CS, RT	11-5026	FDA UDI	Class I	Unknown
Speculum Barraquer Angled Nasal	31-2002	FDA UDI	Class I	Active
Scissors Suture Removal	HR255	FDA UDI	Class I	Active
Needle Holder Troutman	91-7004	FDA UDI	Class I	Active
Towel Clip Backhaus	90-5050	FDA UDI	Class I	Active
Scissors Tenotomy Straight, Pointed Tip 11cm	HR281	FDA UDI	Class I	Active
Forceps St Martins 0.3mm Toothed, O/L 90mm	10-1204	FDA UDI	Class I	Active
Desmarres Retractor 14mm	90-9013	FDA UDI	Class I	Active
Forceps Capsulorhexis MICS 1.8mm, SS, ST	11-5027	FDA UDI	Class I	Active
Scissors Westcott Straight Blunt	20-4006	FDA UDI	Class I	Active
Full Biopsy Set	79-0012A	FDA UDI	Class I	Active
Bonn Forceps Straight 0.12mm Toothed, O/L 102mm	10-1108	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata Mics Ss St	11-5050BNS	FDA UDI	Class I	Active
Forceps Capsulorhexis Inamura, SS, ST	11-5011	FDA UDI	Class I	Active
Chopper Koch 1.9mm	41-4009	FDA UDI	Class I	Active
Den VA Cataract Instrument Pack	67-0021	FDA UDI	Class I	Active
Ophthalmic Suture Removal Set	210	FDA UDI	Class I	Active
Phaco Chopper Melonies Double Ended	41-9010	FDA UDI	Class I	Active
Manipulator Spatula Neuhann	41-3005	FDA UDI	Class I	Active
Manipulator Sadiq/Mushroom	41-9012	FDA UDI	Class I	Active
Forceps Suture Moorfields Utility	10-1311	FDA UDI	Class I	Active
Forceps Adson Toothed Fine Tip	HR122	FDA UDI	Class I	Active
Alchohol Well	51-0002	FDA UDI	Class I	Active
Forceps Capsulorhexis Inamura, CS, ST	11-5021	FDA UDI	Class I	Active
Needle Holder Castroviejo Without Lock	90-7002	FDA UDI	Class I	Active
Forceps Epilation Angled	10-1300	FDA UDI	Class I	Active
Needle Holder Halsey 13cm	HR520	FDA UDI	Class I	Active
Full Excision Set	79-0016	FDA UDI	Class I	Active
Forceps Jewellers #5	10-2005	FDA UDI	Class I	Active
Speculum Barraquer Straight	30-2004	FDA UDI	Class I	Active
Scissor Tenotomy Curved Round Tip	HR286	FDA UDI	Class I	Active
Speculum Leibinger Solid Blade	31-3000	FDA UDI	Class I	Active
Speculum Buratto	30-3001	FDA UDI	Class I	Active
Retractor West Self Retaining (Sharp)	HR704	FDA UDI	Class I	Active

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