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
Barraquer Needel Holder Cvd Without Lock	D60-3630	EUDAMED	Class I	Active
Corneal Dissector	D30-3661	EUDAMED	Class I	Active
Keratoplasty Hook	D30-19091	EUDAMED	Class I	Active
TITANIUM RETINAL Serrated ILM Forceps, 1.25mm 20G str	DT50-7507	EUDAMED	Class I	Active
Iris Spatula	D30-37825B	EUDAMED	Class I	Active
Mushroom Tip & Spatula	D30-090	EUDAMED	Class I	Active
Hartmann Mosquito Fcps Cvd	D50-9910	EUDAMED	Class I	Active
TITANIUM Chang-Seibel a combination chopper	DT30-2341	EUDAMED	Class I	Active
Long Glaucoma Lid Speculum Left	D10-15681L	EUDAMED	Class I	Active
RETINAL Foreign Body Forceps 20G	D50-7518	EUDAMED	Class I	Active
Koch Nucleus Spatula, Smooth.	D30-2354	EUDAMED	Class I	Active
Needle Holder Cvd W/Lock	D60-3820	EUDAMED	Class I	Active
DSAEK Descemet's Scraper	DT30-131	EUDAMED	Class I	Active
Sinskey Hook and Y Bechurt Titanium	DT30-092	EUDAMED	Class I	Active
Koch Nucleus Spatula, With Notches.	D30-2355	EUDAMED	Class I	Active
Nugent Utility Forceps Serrated Jaws	D50-6215	EUDAMED	Class I	Active
TITANIUMRETINAL Eckardt End-gripping 23G	DT50-7515	EUDAMED	Class I	Active
Temporal Approaach Wire Speclum, Closed Wire.	D10-5012	EUDAMED	Class I	Active
Prk Scraper	D30-8003	EUDAMED	Class I	Active
Corcelle Eye Speculum 12mm	D10-8114	EUDAMED	Class I	Active
Castroviejo Caliper Straight	D30-9000	EUDAMED	Class I	Active
Neuhann Nucleus Divider Spatula.	D30-2388	EUDAMED	Class I	Active
TITANIUM Hwang Phaco Chopper 1MM	DT30-2374	EUDAMED	Class I	Active
Hwang Phaco Chopper 1MM	D30-2374	EUDAMED	Class I	Active
Mushroom Iol Manipulator 0.65 Dia	D30-2696	EUDAMED	Class I	Active
Manson Double-Ended Strabismus Hook	D30-6805	EUDAMED	Class I	Active
Iol Removal Scissors Str 8mm With Serrated Lower Bld	D40-1691	EUDAMED	Class I	Active
Mcdonald Ii Iol Inserting Forceps Extra Del.	D50-8237	EUDAMED	Class I	Active
Rowen D-E Phaco Spatula	D30-2398	EUDAMED	Class I	Active
Barraquer Ndl Holder Cvd Del Without Lock	D60-3530	EUDAMED	Class I	Active
John DSAEK Stromal Scrubber	D30-183	EUDAMED	Class I	Active
Jewelers Forceps Str Del #3	D50-6530	EUDAMED	Class I	Active
Kuglen Iris Hook Angled	D30-5520	EUDAMED	Class I	Active
Dodick Nucleus Cracker	D50-7244	EUDAMED	Class I	Active
Dodick Iol Folding Forceps	D50-8210	EUDAMED	Class I	Active
Titanium Chang Combination Chopper, Use In Right Hand.	DT30-2368	EUDAMED	Class I	Active
Barraquer Oosterhuis Eye Speculum Solid	D10-5040	EUDAMED	Class I	Active
Fukasaku Snapper Hook	D30-2393	EUDAMED	Class I	Active
Jaffe-Knolle Iris Hook, Blunt Angled.	D30-5090	EUDAMED	Class I	Active
Scleral Plug Forcep	DT50-5517	EUDAMED	Class I	Active
Titanium Lester Iol Manipulator Vaulted Shank.	DT30-2691	EUDAMED	Class I	Active
Kalt Needle Holder Str Del	D60-1800	EUDAMED	Class I	Active
Mushroom tip and Nucleus Splitter	DT30-085	EUDAMED	Class I	Active
TITANIUM RETINAL Asymmetrical End-gripping Forceps 23G	DT50-7513	EUDAMED	Class I	Active
Titanium Castroviejo Needle Holder Str W/Lock	DT60-1560	EUDAMED	Class I	Active
Titanium Hartmann Mosquito Fcps Cvd	DT50-9910	EUDAMED	Class I	Active
Deitz Icl Manipulator	D30-5566	EUDAMED	Class I	Active
TITANIUM Koch Nucleus Chopper	DT30-2386	EUDAMED	Class I	Active
Vannas Capsulotomy Sciss Cvd, 5mm Long Blades	DT40-5010	EUDAMED	Class I	Active
Titanium Dbl End Mushroom/ Spatula	DT30-2700	EUDAMED	Class I	Active

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