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
DIN BASKET SIDE PERFORATED FLAT BASE 480x360x60MM	DJ4566	FDA UDI	Class I	Active
TEST TUBE RACK WITH 10 Compartments, 344x43x43 MM	DJ883531	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DOUBLE FRAME) 105x240MM	DJ4455DCW	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 105x70x25MM	DJ4352	FDA UDI	Class I	Active
LID FOR TEST TUBE BASKET, 120x120 MM	DJ705800	FDA UDI	Class I	Active
S.S PEEL POCH RACKS, 4A, 510x152x152 MM, 4 SPACES	DJ08736	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITHOUT LID, 250x140x50MM	DJ4851	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 480x250x50MM	DJ4618	FDA UDI	Class I	Active
Castroviejo Forceps 0.5mm	D50-25300-2	FDA UDI	Class I	Active
Williams Eye Speculum Small	D10-5500	EUDAMEDFDA UDI	Class I	Active
DIN BASKETS SIDE PERFORATED FLAT BASE 240x250x50MM	DJ4549	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DETENTION FRAME) 535x245MM	DJ4468DTCW	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x240x30MM	DJ4426ER	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DETENTION FRAME) 400x245MM	DJ4466DT	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 250x250x30MM	DJ4416ER	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 240x245x30MM	DJ4478	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x250x60MM	DJ4413CW	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x250x70MM	DJ4414ER	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DOUBLE FRAME) 535x245MM	DJ4468D	FDA UDI	Class I	Active
Sinskey Tying Forceps Str Del	D50-5100	EUDAMEDFDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x240x30MM	DJ4426CW	FDA UDI	Class I	Active
INSTRUMENTS BOX, 170x70x30MM	DJ4859	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 405x250x60MM	DJ4658	FDA UDI	Class I	Active
Titanium Corneal Forcep Ergonomic Oblique 0.1mm	DT50-500096-2	FDA UDI	Class I	Active
TEST TUBE BASKET, 120x120x300 MM	DJ705820	FDA UDI	Class I	Active
Agricola Retractor 3 X 3 Prg.	D10-9550	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 480x480x50MM	DJ4625	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 80x80x40MM	DJ4348	FDA UDI	Class I	Active
Titanium Lieberman Speculum V-Wire 15mm Blade	DT10-5675	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 180x130x20MM	DJ4355	FDA UDI	Class I	Active
Stern-Castroviejo Fixation Forceps 0.5mm W/Lock	D50-2552	EUDAMEDFDA UDI	Class I	Active
SPRI BASKETS (Single Frame), 600x300x150 MM	DJ6034	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DETENTION FRAME) 600x300MM	DJ4641DT	FDA UDI	Class I	Active
SILICONE PIN MAT, 500x300MM	DJ4928	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 275x175x35MM	DJ4363	FDA UDI	Class I	Active
Hofmann-Polack Suturing Forceps 0.2mm	D50-1566	EUDAMEDFDA UDI	Class I	Active
MICRO FINE MESH BASKETS WITH LID 80x80x40MM	DJ4348MM	FDA UDI	Class I	Active
ENDOSCOPE BASKETS, 290x80x52 1	DJ4041	FDA UDI	Class I	Active
ENDOSCOPE BASKETS, 580x160x52	DJ4069	FDA UDI	Class I	Active
Titanium Harms Tying Forceps Cvd Standard	DT50-5410	EUDAMEDFDA UDI	Class I	Active
Titanium Harms Tying Forceps Str Standard	DT50-5400	EUDAMEDFDA UDI	Class I	Active
Endoscope Baskets, 460x160x52	DJ4052	FDA UDI	Class I	Active
PLASTIC AUTOCLAVABLE TRAY 265x160x25MM	D902030	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x245x50MM	DJ4479CW	FDA UDI	Class I	Active
Lieberman Temporal Approch Speculum	D10-5681	EUDAMEDFDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 405x250x100MM	DJ4425	FDA UDI	Class I	Active
Vitrectomy Scissors Vertical Opening Straight 20g	D40-5200	FDA UDI	Class I	Active
LID FOR PERFORATED BASKET (DOUBLE FRAME) 480x480MM	DJ4588	FDA UDI	Class I	Active
LID FOR PERFORATED BASKET (DOUBLE FRAME) 540x250MM	DJ4586	FDA UDI	Class I	Active
Corneal Forceps With Tying 0.12mm	D50-17160	EUDAMEDFDA UDI	Class I	Active

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