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 Tennat Tying Forceps Str Del 6mm Long	DT50-5220	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DETENTION FRAME) 480x240MM	DJ4460DT	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORATED FLAT BASE 540x250x100MM	DJ4564	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORATED FLAT BASE 480x480x100MM	DJ4572	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 240x120x100MM	DJ4609	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 300x180x20MM	DJ4366	FDA UDI	Class I	Active
Titanium Maumenee Tying Forceps Ang	DT50-5235	EUDAMEDFDA UDI	Class I	Active
Titanium Kelman-Mcpherson Forceps Ang	DT50-5030	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 240x250x30MM	DJ4607	FDA UDI	Class I	Active
INSTRUMENTS CASSETTES WITH SPRING HOLDING LID 250x220x40MM	DJ4247	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 405x250x60MM	DJ4423CW	FDA UDI	Class I	Active
Akahoshi Super Combo Iii Prechopper	D350-7233	EUDAMEDFDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 485x245x30MM	DJ4486	FDA UDI	Class I	Active
Speculum, Thorlakson, Rounded, 11mm Blades	D10-5673	EUDAMEDFDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 480x240x60MM	DJ4428	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 405x250x30MM	DJ4656	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (SINGLE FRAME) 535x245MM	DJ4468CW	FDA UDI	Class I	Active
Capsulorrhexis Forceps 12mm	D50-600002	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 105x240x100MM	DJ4405	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (SINGLE FRAME) 240x250MM	DJ4457CW	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x240x60MM	DJ4428ER	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 250x250x30MM	DJ4416	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 250x250x30MM	DJ4416CW	FDA UDI	Class I	Active
Tissue Forceps Del 1x2 Cvd	D50-4110	EUDAMEDFDA UDI	Class I	Active
Castroviejo Suturing Forceps 0.12mm Titanium	DT50-25504	EUDAMEDFDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x245x30MM	DJ4478ER	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x240x30MM	DJ4406ER	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 480x240x30MM	DJ4426	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 105x245x30MM	DJ4475CW	FDA UDI	Class I	Active
Castroviejo Corneoscleral Scissors, Sm Right	D40-1000	EUDAMEDFDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 485x245x50MM	DJ4487ER	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x240 Version or Model Numx70MM	DJ4429CW	FDA UDI	Class I	Active
Tying Forcep 4mm Str	D50-700019-1	EUDAMEDFDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 540x250x60MM	DJ4443CW	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x480x30MM	DJ4436ER	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x250x50MM	DJ4432CW	FDA UDI	Class I	Active
Jaffe Wire Lid Retractor Pair, Sm	D10-8001	EUDAMEDFDA UDI	Class I	Active
Frankel Infant Eye Speculum Adjustable	D10-5310	FDA UDI	Class I	Active
IDENTIFICATION S.S TRAY TAGS, 90x35MM	DJ4933	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 240x245MM	DJ4465	FDA UDI	Class I	Active
TEST TUBE RACK WITH 52 Compartments, 290x98x80 MM	DJ883450	FDA UDI	Class I	Active
Fixation Forceps 0.50mm 1x2	D50-700010	EUDAMEDFDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 480x250x60MM	DJ4619	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DETENTION FRAME) 480x480MM	DJ4639DT	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 480x250MM	DJ4461	FDA UDI	Class I	Active
Lieberman Speculum Solid Lg	D10-5678	EUDAMEDFDA UDI	Class I	Active
Bechert Forceps Angled 10mm	D50-5049	FDA UDI	Class I	Active
Hoskin #28 Tissue Forceps Del Colibri Style	D50-1728	EUDAMEDFDA UDI	Class I	Active
Hoffer-Mcpherson Forceps Del 11m Long Jaws	D50-2350	EUDAMEDFDA UDI	Class I	Active
Hoskin #22 Tissue Forceps Colibri Style	D50-1722	FDA UDI	Class I	Active

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