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
FULL MICRO PERFORATED TRAYS WITH LID 225x110x50MM	DJ2359	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x240x100MM	DJ4410ER	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (SINGLE FRAME) 480x480MM	DJ4639	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 485x245MM	DJ4467	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 225x110x50MM	DJ4368	FDA UDI	Class I	Active
Castroviejo Forceps 0.9mm	D50-25300-3	FDA UDI	Class I	Active
CATHETER TRAY 250x75x40MM	DJ4868	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x240x100MM	DJ4430ER	FDA UDI	Class I	Active
DIN BASKETS SIDE PERFORATED FLAT BASE 120x250x50MM	DJ4545	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM	DJ4848	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DETENTION FRAME) 500x300MM	DJ4640DT	FDA UDI	Class I	Active
Titanium Corneal Forcep 90mm W/Tying 0.3mm	DT50-500097-1	FDA UDI	Class I	Active
MICRO FINE MESH BASKETS WITH LID 180x130x20MM	DJ4355MM	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DOUBLE FRAME) 480x480MM	DJ4462D	FDA UDI	Class I	Active
S.S PEEL POCH RACKS, 18B, 533x203x203 MM, 10 SPACES	DJ08734	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (SINGLE FRAME) 405x250MM	DJ4642	FDA UDI	Class I	Active
BUR HOLDER STAND, 63x25x30 12 HOLES	DJ3093	FDA UDI	Class I	Active
Bonn Forceps Short 0.12mm	D50-2000	EUDAMEDFDA UDI	Class I	Active
Hoskin #18 Tissue Forceps Str	D50-1718	EUDAMEDFDA UDI	Class I	Active
Titanium Capsulorrhexis Forceps Ergonomic Handle	D50-80001234	EUDAMEDFDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DOUBLE FRAME) 240x120MM	DJ4635D	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DOUBLE FRAME) 540x250MM	DJ4643D	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x480x100MM	DJ4440CW	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x250x60MM	DJ4433CW	FDA UDI	Class I	Active
LID FOR PERFORATED BASKET (DOUBLE FRAME) 405x250MM	DJ4584	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 240x250x100MM	DJ4617	FDA UDI	Class I	Active
STORZ Utrata Capsulorhexis Forceps	D50-2002S	FDA UDI	Class I	Active
Kelman-Mcpherson Forceps 8mm Long Jaws, 0.3mm	D50-2330	EUDAMEDFDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 105x240x50MM	DJ4402	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DETENTION FRAME) 480x250MM	DJ4461DT	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DOUBLE FRAME) 480x480MM	DJ4639D	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 105x240x70MM	DJ4404CW	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 220x140x50MM	DJ4358	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 540x250x100MM	DJ4445CW	FDA UDI	Class I	Active
SPRI BASKETS (with Folding Handle), 585x395x195 MM	DJ6011	FDA UDI	Class I	Active
Corneal Forceps 0.12 With Tying Platform Ergonomic	D50-500094	FDA UDI	Class I	Active
Urinals Chamber	DJ4916	FDA UDI	Class I	Active
Infant Wire Speculum Blades size 6mm, Solid	D10-5330	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITH LID, 200x150x40MM	DJ4838	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 400x245x70MM	DJ4484ER	FDA UDI	Class I	Active
STERILE GOODS BASKETS, 575x280x135 MM STANDARD	DJ5010	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DOUBLE FRAME) 240x245MM	DJ4465DCW	FDA UDI	Class I	Active
Masket CAPSULORRHEXIS FORCEPS, LONG	D50-5074	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DOUBLE FRAME) 405x250MM	DJ4642D	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 405x250x70MM	DJ4424ER	FDA UDI	Class I	Active
Castroviejo Suturing Forceps 0.12mm Titanium	DT50-2500	FDA UDI	Class I	Active
FINE MESH BASKETS WITH LID 150x50x35MM	DJ4354	FDA UDI	Class I	Active
Bishop-Harmon Forceps Standard	D50-3510	EUDAMEDFDA UDI	Class I	Active
Anis Tying Forceps Cvd Del	D50-5113	EUDAMEDFDA UDI	Class I	Active
Castroveijo Suturing Forcep 0.90	D50-700011-4	EUDAMEDFDA UDI	Class I	Active

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