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
TITANIUM Tuebingen Model Tying forceps str	DT50-19030	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DOUBLE FRAME) 480x240MM	DJ4460D	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITH LID, 230x150x50MM	DJ4839	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITH LID, 450x300x50MM	DJ4846	FDA UDI	Class I	Active
FINE MESH CASSETTES FOR MICRO INSTRUMENTS 235x80x30MM	DJ4149	FDA UDI	Class I	Active
Sauer Fixation Forceps	D50-3560	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 250x250x50MM	DJ4417CW	FDA UDI	Class I	Active
Clark Speculum Premature Baby	D10-7157-3	EUDAMEDFDA UDI	Class I	Active
Titanium Gerl Tying Forcep	DT50-5215	FDA UDI	Class I	Active
Holding Pins For Partition Sheet	DJ4920A	FDA UDI	Class I	Active
SPRI BASKETS (Single Frame), 600x300x200 MM	DJ6036	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x250x30MM	DJ4411CW	FDA UDI	Class I	Active
Tying Forcep 8mm Ang	D50-700019-4	EUDAMEDFDA UDI	Class I	Active
SCALER TRAYS 225x100MM	DJ4896	FDA UDI	Class I	Active
INSTRUMENTS BOX, 200x100x40MM	DJ4861	FDA UDI	Class I	Active
Kurstin Flap Stretching Forceps	D50-5056	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 240x245x70MM	DJ4480	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 485x245x70MM	DJ4488ER	FDA UDI	Class I	Active
BUR HOLDER STAND, 40x75x25 6 HOLES	DJ3080	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x250x50MM	DJ4412ER	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 485x245x100MM	DJ4489CW	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 400x245x50MM	DJ4483	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 540x250x100MM	DJ4665	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x250x30MM	DJ4431ER	FDA UDI	Class I	Active
S.S PEEL POCH RACKS, 13, 533x203x203 MM, 6 & 7 SPACES	DJ08733	FDA UDI	Class I	Active
VITRECTOMY SCISSORS VERTICAL OPENING 80Deg ANG 20G	D40-5250	FDA UDI	Class I	Active
Mcpherson Tying Forceps Str	D50-5000	EUDAMEDFDA UDI	Class I	Active
Kelman-Mcpherson Forceps Ang	D50-5030	EUDAMEDFDA UDI	Class I	Active
MICRO FINE MESH BASKETS WITH LID 141x50x40MM	DJ4353MM	FDA UDI	Class I	Active
Jaffe Tying Forceps Straight	D50-5200	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 105x240x100MM	DJ4405CW	FDA UDI	Class I	Active
Barraquer Wire Speculum Infant	D10-5355	FDA UDI	Class I	Active
Titanium Vitrectomy Scissors Vertical Opening Str 20g	DT40-5200	EUDAMEDFDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 235x120x60MM	DJ4369	FDA UDI	Class I	Active
TEST TUBE RACK WITH 44 Compartments, 246X98X80 MM	DJ883451	FDA UDI	Class I	Active
CATHETER TRAY 230x80x50MM	DJ4869	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DETENTION FRAME)400x245MM	DJ4466DTCW	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITHOUT LID, 450x300x50MM	DJ4857	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITHOUT LID, 200x150x40MM	DJ4849	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITH LID, 200x100x25MM	DJ4837	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITH LID, 400x300x50MM	DJ4845	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DOUBLE FRAME) 240x250MM	DJ4457DCW	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 300x300x50MM	DJ4622	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 480x240MM	DJ4460	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 485x245x30MM	DJ4486CW	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 250x250x100MM	DJ4420	FDA UDI	Class I	Active
Utrata Capsulorrhexis Forceps, Short	D50-5071	FDA UDI	Class I	Active
MICRO CASSETTES 74x45x20	DJ3041	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 405x250x30MM	DJ4421	FDA UDI	Class I	Active
Holding Pins For Instruments	DJ4920	FDA UDI	Class I	Active

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