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
Needle Holder Crilewood 15cm	HR510	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata Round Handle, CS, ST	11-5013	FDA UDI	Class I	Active
Scissors Tenotomy Curved, Pointed Tip 11cm	HR283	FDA UDI	Class I	Active
Scissors Iris Sharp Curved 10cm	HR210	FDA UDI	Class I	Active
Forceps Cutting Angled Serrated 7cm	HR141	FDA UDI	Class I	Active
Forceps Mosquito Curved 13cm	HR400	FDA UDI	Class I	Active
Forceps Capsulorhexis Utrata MICS CS GT	11-5053	FDA UDI	Class I	Active
RC Kit 1	67-0018A	FDA UDI	Class I	Active
Scissors Dressing Stitch Sharp/Blunt 15cm	HR250	FDA UDI	Class I	Active
Forceps Jewellers #7	11-2007	FDA UDI	Class I	Active
Forceps Mosquito Curved 9cm	HR405	FDA UDI	Class I	Active
Toric Degree Gauge 11.7mm I.D	91-6000	FDA UDI	Class I	Active
Forceps Colibri 0.25mm Toothed O/L 84mm	11-7010	FDA UDI	Class I	Active
Caliper & Rule	90-1014	FDA UDI	Class I	Active
Barraquer Neonatal Speculum with Finger tips	31-3103	FDA UDI	Class I	Active
Forceps Mosquito Straight 13cm	HR420	FDA UDI	Class I	Active
Retractor Langenbeck	HR702	FDA UDI	Class I	Active
Chopper Koch 1.4mm	41-4008	FDA UDI	Class I	Active
Clip Towel Backhaus 8cm	HR800	FDA UDI	Class I	Active
Stevens Tenotomy Scissors 11cm Curved Blunt Tip	HS291	FDA UDI	Class I	Active
Thornton Ring	90-1020	FDA UDI	Class I	Active
Speculum Leibinger	31-3002	FDA UDI	Class I	Active
Clamp Chalazion Medium	90-4006	FDA UDI	Class I	Active
Forceps Mosquito Straight 10cm	10-1006	FDA UDI	Class I	Active
Scalpel Handle BP No 3	HR300	FDA UDI	Class I	Active
Speculum Leibinger	31-3002	FDA UDI	Class I	Active
Scissors Metzenbaum Curved 18cm	HR270	FDA UDI	Class I	Active
Kaiser AMD Set	67-0026	FDA UDI	Class I	Active
Manipulator Lens Hook Sinskey Angled	41-5001	FDA UDI	Class I	Active
Clamp Chalazion Large	90-4007	FDA UDI	Class I	Active
Needle Holder Castroviejo With Lock	90-7001	FDA UDI	Class I	Active
Scissors Iris Straight Blunt 10cm	20-7001	FDA UDI	Class I	Active
Minor Ops Set	79-0014A	FDA UDI	Class I	Active
Forceps Epilation Angled	HR131	FDA UDI	Class I	Active
Speculum Kratz-Barraquer Angled Temporal	31-1006	FDA UDI	Class I	Active
Forceps Capsulorhexis MICS 1.8mm, CS, ST	11-5023	FDA UDI	Class I	Active
Speculum Neo-Natal Angled Temporal	31-3100	FDA UDI	Class I	Active
Manipulator Lester IOL	41-1006	FDA UDI	Class I	Active
Speculum Solid Blade	31-4002	FDA UDI	Class I	Active
Needle Holder Parkhouse	HR526	FDA UDI	Class I	Active
Forceps Iris 11cm Serrated	HR130	FDA UDI	Class I	Active
Intra Vitreoretinal Injection Set	023	FDA UDI	Class I	Active
Cannula Kit 1 - Kaiser Permanente Martinez	67-0009	FDA UDI	Class I	Active
Skin Hook McIndoe 5mm Hook	HR942	FDA UDI	Class I	Active
Adson Forceps Brown	10-1307	FDA UDI	Class I	Active
Scissors Mayo Straight 14cm	HR262	FDA UDI	Class I	Active
Forceps Tying Mcpherson 5mm Platform O/L 90mm	10-9009	FDA UDI	Class I	Active
Toric Alignment Marker, 3, 6, 9 O'Clock	91-6001	FDA UDI	Class I	Active
USA Universal Cataract Inst Set	76-0026	FDA UDI	Class I	Unknown
Forceps Hoskins Straight 0.3mm Notched O/L 90mm	10-8008	FDA UDI	Class I	Active

BLINK MEDICAL LIMITED

What BLINK MEDICAL LIMITED makes

Frequently asked questions

Information

Catalogue (250)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)