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
Scissors Westcott Curved Std Tip	21-4010	FDA UDI	Class I	Active
Scissors Ong	21-3010	FDA UDI	Class I	Active
Forceps Bonn Straight 0.25mm Toothed O/L 84mm	10-1105	FDA UDI	Class I	Active
Capsulorhexis Forceps, Utrata Round Handle, CS, GT	11-5014	FDA UDI	Class I	Active
Speculum Paediatric Spring	30-3002	FDA UDI	Class I	Active
RC Kit 2	67-0010	FDA UDI	Class I	Active
Stockton Kit 2	67-0014A	FDA UDI	Class I	Active
Stevens Tenotomy Scissors 11cm Curved Sharp Tip	HS290	FDA UDI	Class I	Active
Manipulator Sinskey Straight Lens Hook	40-5002	FDA UDI	Class I	Active
Curette Double Ended 2mm&4mm Cups	90-3009	FDA UDI	Class I	Active
AAV Instrument Pack	67-0025	FDA UDI	Class I	Active
Scissors Strabismus Straight	HR241	FDA UDI	Class I	Active
Needle Holder Delicate Curve	91-7003	FDA UDI	Class I	Active
Scissors Stevens Tenotomy Serrated/Curved 12.5cm	HR282	FDA UDI	Class I	Active
Westcott Scissors Curved Sharp Tip	21-4014	FDA UDI	Class I	Active
Probe Liebricht 1+2	90-2010	FDA UDI	Class I	Active
Epithelial Spatula, Rounded Tip	51-0003	FDA UDI	Class I	Active
Phaco Chopper Mcphearson	41-3006	FDA UDI	Class I	Active
Forceps Bonn Straight 0.25mm Toothed O/L 106mm	10-1106BNS	FDA UDI	Class I	Active
Forceps Jewellers Straight	HR142	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata, SS, ST	11-5022	FDA UDI	Class I	Unknown
Speculum Kratz-Barraquer Curved Angled Temporal	31-1009	FDA UDI	Class I	Active
Scissors Metzenbaum Straight 18cm	HR271	FDA UDI	Class I	Active
Forceps Adson Non Toothed 1.5mm Tip	HR125	FDA UDI	Class I	Active
Stockton Kit #1	67-0017	FDA UDI	Class I	Active
Retractor Kilner Catspaw	HR700	FDA UDI	Class I	Active
Speculum Barraquer Angled Temporal	31-2003	FDA UDI	Class I	Active
Forceps Bonn Straight 0.25mm Toothed O/L 90mm	10-1107	FDA UDI	Class I	Active
Needle Holder Halsey Smooth Narrow Jaw 13cm	HR519	FDA UDI	Class I	Active
Scissors Dressing Stitch Sharp/Blunt 13cm	HR251	FDA UDI	Class I	Active
Skin Hook Fine 2mm Hook	HR940	FDA UDI	Class I	Active
Probe Liebricht 0000+000	90-2007	FDA UDI	Class I	Active
Forceps Capsulorhexis Inamura Round Handle CS, ST	11-5020	FDA UDI	Class I	Active
Forceps Angled Jewellers 7mm Tip	HR101	FDA UDI	Class I	Active
Forceps Mosquito Curved 10cm	11-1005	FDA UDI	Class I	Active
Biopsy Set	79-0011	FDA UDI	Class I	Active
Speculum Barraquer Solid Blade	30-4000	FDA UDI	Class I	Active
Foreign Body Removal Set	76-0073	FDA UDI	Class I	Active
Speculum Barraquer Solid Plastic Blade	31-4001	FDA UDI	Class I	Active
Forceps Jewellers #1	10-2001	FDA UDI	Class I	Active
Manipulator Nucleus Y Shaped Horizontal Axis	41-2005	FDA UDI	Class I	Active
Probe Liebricht 00+0	90-2009	FDA UDI	Class I	Active
Capsulorhexis Forceps, Utrata Round Handle, SS, GT	11-5015	FDA UDI	Class I	Active
Chalazion Set - Medium	111	FDA UDI	Class I	Active
Chalazion Set - Small	092	FDA UDI	Class I	Active
Skin Hook Standard 3mm Hook	HR941	FDA UDI	Class I	Active
Dialator Nettle Ship	90-1012	FDA UDI	Class I	Active
Bulldog Clamp	90-8012	FDA UDI	Class I	Active
Phaco Chopper Sadiq	41-4005	FDA UDI	Class I	Active
Forceps Colibri 0.25mm Toothed O/L 108mm	11-7011	FDA UDI	Class I	Active

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