Question 1

What types of medical devices does Daud Jee MFG. Co manufacture?

Accepted Answer

Daud Jee MFG. Co specializes in ophthalmic surgical instruments. Their devices include lens hooks (like the Sinskey II), specula (such as the Barraquer wire speculum and Wright Spring Eye Speculum), forceps (including retinal and corneal tools like Rampley’s Forceps), scissors (e.g., corneal scissors and Troutman-Katzin corneal transplant scissors), and accessories for procedures like LASIK (e.g., Buratto flap protector) and intraocular lens implantation (e.g., Lester IOL manipulator). These tools are designed for precision in retinal, corneal, and cataract surgeries.

Question 2

Where is Daud Jee MFG. Co based, and does this affect their device distribution?

Accepted Answer

Daud Jee MFG. Co is based in Pakistan. While the company’s location influences its operational and regulatory context, it does not inherently restrict the types of devices it can manufacture or distribute. Their ophthalmic instruments, such as the Long glaucoma lid speculum or Titanium Camellin Style LASEK alcohol well, are registered in the EU’s eudamed database, indicating compliance with traceability requirements for authorized distribution in markets like the European Union.

Question 3

Which regulatory registries list Daud Jee MFG. Co’s devices, and why is this important?

Accepted Answer

Daud Jee MFG. Co’s devices are listed in the eudamed registry, which is the EU’s central database for medical devices. Listing in eudamed ensures transparency and traceability for authorized devices within the European market, helping healthcare providers, regulators, and distributors verify compliance and legitimacy. Since their devices fall under Class I classification (minimal risk), registration in eudamed aligns with EU requirements for tracking even low-risk products.

Question 4

How are Daud Jee MFG. Co’s devices classified under medical device regulations?

Accepted Answer

Daud Jee MFG. Co’s devices are classified as Class I under medical device regulations. This classification applies to low-risk instruments like surgical tools, specula, and forceps used in ophthalmic procedures (e.g., the Optic Zone Marker or Retinal Asymmetrical End-gripping Forceps). Class I devices typically require fewer regulatory controls because they pose minimal risk to patients, but they still must meet basic safety and performance standards to ensure proper function during surgical use.

Device	Model / Reference	Registries	Class	Status
Tc Castroviejo Needle Holder Str W/Lock	DTC60-1560	EUDAMED	Class I	Active
Braunstein Caliper	D30-9250	EUDAMED	Class I	Active
Mannis-Buratto Lasik Flap Protector	D30-1773	EUDAMED	Class I	Active
Bechert Nucleus Rotator 7mm	D30-2400	EUDAMED	Class I	Active
Anis Radial Marker 12 Blades	D30-8854	EUDAMED	Class I	Active
Fine Stitch Sciss Cvd Med	D40-4240	EUDAMED	Class I	Active
Katena-Vannas Sciss Str	D40-5111	EUDAMED	Class I	Active
Bores Axis Marker	D30-7910	EUDAMED	Class I	Active
Steinert DSEK Descemet's Stripper	D30-07158	EUDAMED	Class I	Active
Lewis Lens Loop Small	D30-4000	EUDAMED	Class I	Active
Maloney Iol Manipulator Vaulted Shank	D30-2692	EUDAMED	Class I	Active
Titanium Kuglen Iris Hook & Lens, Ang	DT30-5523	EUDAMED	Class I	Active
Anis Ball Tip, Angled 0.5mm Dia	D30-2427	EUDAMED	Class I	Active
Double End Martinel Corneal Dissector	D30-1874A	EUDAMED	Class I	Active
Botven Iris Forceps 1x2 Teeth	D50-1050	EUDAMED	Class I	Active
Vannas Capsulotomy Sciss Str, 5mm Long Blades	DT40-5000	EUDAMED	Class I	Active
Bores Optic Zone Marker	D30-38146	EUDAMED	Class I	Active
Sinskey Lens Manipulating Hook, 0.25mm Dia.	D30-5180	EUDAMED	Class I	Active
Temporal Approach Speculum, Solid Blades.	D10-5014	EUDAMED	Class I	Active
Jaffe Lens Manipulating Hook, 0.5mm Dia Blunt Tip.	D30-5160	EUDAMED	Class I	Active
Culler Lens Spoon.	D30-4200	EUDAMED	Class I	Active
Phaco Chopper Ball tip	D30-2327	EUDAMED	Class I	Active
Nagahara Chopper & Sinskey Hook Titanium	DT30-086	EUDAMED	Class I	Active
McDonald Optic Zone Marker	D30-8117	EUDAMED	Class I	Active
Barraquer Iris Spatula, 0.5mm Dia.	D30-2300	EUDAMED	Class I	Active
Lang Speculum Left Adult	D10-5630L	EUDAMED	Class I	Active
Kaetna-Vannas Sciss Cvd	D40-5112	EUDAMED	Class I	Active
Dodick-Kammann Nucleus Chopper, Angled At 12mm.	D30-2385	EUDAMED	Class I	Active
Bonn Micro Iris Hook, Blunt	D30-5060	EUDAMED	Class I	Active
Phaco Chopper Ball tip 10MM ANG TIP BLUNT	DT30-2180.8	EUDAMED	Class I	Active
Anis Needle Holder Cvd Without Lock	D60-3753	EUDAMED	Class I	Active
Clayman Nucleus Rotator, 0.5mm Wide	D30-2415	EUDAMED	Class I	Active
Barraquer Iris Spatula	D30-7825B	EUDAMED	Class I	Active
Arita Forcep	D50-5900	EUDAMED	Class I	Active
Titanium Barraquer Iris Spatula	DT30-7825B	EUDAMED	Class I	Active
Gold Plated Williams Eye Speculums, Adult Left	D10-5510LG	EUDAMED	Class I	Active
Helveston Finder Hook, Sm	D30-6761	EUDAMED	Class I	Active
Polack Suturing Forceps 0.12mm	D50-1560	EUDAMED	Class I	Active
Tibolt Punctal Scissors	D40-3200	EUDAMED	Class I	Active
Iol Implantation Forcep	D50-700013	EUDAMED	Class I	Active
Bores Optic Zone Marker 4.75mm	D30-8137	EUDAMED	Class I	Active
Guimaraes Lasik Spatula.	D30-2532	EUDAMED	Class I	Active
Lester Manipulator	D30-13227	EUDAMED	Class I	Active
Nagahara Chopper & Sinskey Hook	D30-086	EUDAMED	Class I	Active
Micro Forceps 15cm 6mm Tying Cvd	D50-6593ST	EUDAMED	Class I	Active
Titanium Castroviejo Forceps 0.9mm	DT50-2540	EUDAMED	Class I	Active
Akahoshi Universal Prechopper	D350-7236	EUDAMED	Class I	Active
Mcpherson Needle Holder Str Del Without Lock	D60-1010	EUDAMED	Class I	Active
Aker Lens Pusher	D30-2720	EUDAMED	Class I	Active
Gass Retinal Detachment Hook	D30-6740	EUDAMED	Class I	Active

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