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
Hoffer Optic Zone Marker W/Cross Hairs 3.25mm	D30-8340	EUDAMED	Class I	Active
Backhaus Towl Clamp 90mm Long	D50-9964	EUDAMED	Class I	Active
Benedetto Spatula	D30-2522	EUDAMED	Class I	Active
PATON Spatula and Spoon	D30-4256	EUDAMED	Class I	Active
Hoffer Optic Zone Markers	D30-38390	EUDAMED	Class I	Active
DALK Rosenwasser DALK Trisector	D30-1875	EUDAMED	Class I	Active
Lindstorm Small Incision Marker	D30-8960	EUDAMED	Class I	Active
Koch Nucleus Chopper	D30-2386	EUDAMED	Class I	Active
Chavasse Strabismus Hook	D30-6783	EUDAMED	Class I	Active
PATON Spatula and Spoon	DT30-4256	EUDAMED	Class I	Active
Katena-Vannas Sciss Cvd	D40-5122	EUDAMED	Class I	Active
Castroviejo Corneoscleral Scissors, Med Lift	D40-1200	EUDAMED	Class I	Active
Paton Spatula & Spoon.	D30-4255	EUDAMED	Class I	Active
Lang Speculum Right Infant	D10-5628R	EUDAMED	Class I	Active
Kirby Lens Loop & Expressor	D30-4105	EUDAMED	Class I	Active
Bores Optic Zone Marker 4.25mm	D30-8135	EUDAMED	Class I	Active
Grandon-Barraquer Wire Speclum.	D10-5011	EUDAMED	Class I	Active
Titanium Jewelers Forceps Cvd #7	DT50-6570	EUDAMED	Class I	Active
Castroviejo Sciss Cvd Lg	D40-2260	EUDAMED	Class I	Active
Bores Optic Zone Marker 3.50mm	D30-8132	EUDAMED	Class I	Active
Femto Spatula, Blunt	D30-2442	EUDAMED	Class I	Active
Helveston Fixation Forceps Right	D50-2556	EUDAMED	Class I	Active
Sinskey 11 Lens Hook, 0.2mm Dia Blunk Tip Str.	D30-5232	EUDAMED	Class I	Active
Titanium Castroviejo Forceps 0.3mm	DT50-2510	EUDAMED	Class I	Active
Twist Hook, Lift	D30-6110	EUDAMED	Class I	Active
Lewis Lens Loop Large	D30-4010	EUDAMED	Class I	Active
Clasen Manipulator	D30-5564	EUDAMED	Class I	Active
Buratto Soft Iol Inserting Forceps Del	D50-8268	EUDAMED	Class I	Active
Titanium Kuglen Iris Hook & Lens, Str.	DT30-5522	EUDAMED	Class I	Active
Chang-Seibel a combination chopper	D30-2341	EUDAMED	Class I	Active
Milder Phaco Chopper 60 DEGREE double-end	D30-2345	EUDAMED	Class I	Active
Hoffer Optic Zone Marker W/Cross Hairs 8.0mm	D30-8422	EUDAMED	Class I	Active
Hunkeler Iol Manipulator With 0.3mm Dia.	D30-2695	EUDAMED	Class I	Active
Fine-Thornton Fix Ring 16mm	D30-6163	EUDAMED	Class I	Active
Baird Chalazion Forceps	D50-9550	EUDAMED	Class I	Active
Titanium Henderson Alignment Marker clockwire 3, 6 & 9	DT30-7908	EUDAMED	Class I	Active
Bores Optic Zone Markers	D30-38150	EUDAMED	Class I	Active
Du Plessis Muscle Hook	D30-6814	EUDAMED	Class I	Active
Slade Refractive Spatula	D30-32527	EUDAMED	Class I	Active
Uribe-Stern Sciss Cvd, Angled	D40-5125	EUDAMED	Class I	Active
Bores Optic Zone Marker 4.0mm	D30-8134	EUDAMED	Class I	Active
Nagahara blunt Chopper & Spatula Titanium	DT30-088	EUDAMED	Class I	Active
Gimbel Nucleus Spatula, 0.25mm Dia.	D30-2312	EUDAMED	Class I	Active
Lester Iol Manipulator Str, With Guard.	D30-2680	EUDAMED	Class I	Active
Wright Grooved Hook	D30-6732	EUDAMED	Class I	Active
Titanium Braunstein Fixed Caliper 80MM	DT30-2-100	EUDAMED	Class I	Active
Chang-Seibel a combination chopper	D30-2340	EUDAMED	Class I	Active
Stitch Scissors Ribbon Type	D40-8100	EUDAMED	Class I	Active
TITANIUM MICS/MCCS Capsulorhexis 23G	DT50-600001	EUDAMED	Class I	Active
Hugonnier-Gobin hook Very Delicate	D30-13010	EUDAMED	Class I	Active

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