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 Corneal Forcep 90mm W/Tying 0.1mm Oblique	DT50-500097-2	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 535x245x100MM	DJ4493	FDA UDI	Class I	Active
TEST TUBE RACK 9+1, 96x78x65 MM	DJ705853	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x240x60MM	DJ4408CW	FDA UDI	Class I	Active
Mellinger Eye Speculum	D10-5411	EUDAMEDFDA UDI	Class I	Active
Mcpherson Tying Forcep Ergonomic Handle 7mm Cvd	D50-600008	EUDAMEDFDA UDI	Class I	Active
DIN BASKET SIDE PERFORATED FLAT BASE 480x360x70MM	DJ4567	FDA UDI	Class I	Active
TEST TUBE RACK W/36 Compartments, 202x98x160 MM	DJ883452	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 240x245x70MM	DJ4480ER	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (SINGLE FRAME) 480x240MM	DJ4460CW	FDA UDI	Class I	Active
INSTRUMENTS TRAYS WITHOUT LID, 350x250x50MM	DJ4854	FDA UDI	Class I	Active
SPRI BASKETS (Single Frame), 600x400x200 MM	DJ6041	FDA UDI	Class I	Active
Titanium Short Handle Bonn Corneal Forcep 0.12	DT50-5516	EUDAMEDFDA UDI	Class I	Active
Castroviejo Forceps 0.3mm	D50-2510	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (DETENTION FRAME) 480x480MM	DJ4462DT	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 535x245x30MM	DJ4490ER	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 400x245x50MM	DJ4483CW	FDA UDI	Class I	Active
TITANIUM STORZ Utrata Capsulorhexis Forceps	DT50-2002	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 240x250x70MM	DJ4414	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 485x245x30MM	DJ4486ER	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DETENTION FRAME) 405x250MM	DJ4459DTCW	FDA UDI	Class I	Active
Clark Speculum Adult	D10-7157	EUDAMEDFDA UDI	Class I	Active
DIN BASKET SIDE PERFORATED FLAT BASE 540x250x60MM	DJ4562	FDA UDI	Class I	Active
MICRO FINE MESH BASKETS WITH LID 150x50x35MM	DJ4354MM	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 540x250MM	DJ4463	FDA UDI	Class I	Active
PLASTIC AUTOCLAVABLE TRAY 160x70x25MM	D902020	FDA UDI	Class I	Active
LID FOR PERFORATED BASKETS (DETENTION FRAME) 405x250MM	DJ4642DT	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 240x240x100MM	DJ4410	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 405x250x50MM	DJ4422ER	FDA UDI	Class I	Active
CATHETER TRAY 300x80x40MM	DJ4870	FDA UDI	Class I	Active
STANDARD WIRE MESH BASKET WITH DROP HANDLES 105x245x30MM	DJ4475	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 480x480x60MM	DJ4626	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORATED FLAT BASE 480x480x60MM	DJ4570	FDA UDI	Class I	Active
Colibri Forcep 0.4 W/Tying Platform	D50-118950-2	EUDAMEDFDA UDI	Class I	Active
Flieringa Scleral Fixation Ring, Set Of ( 8 ) Sizes.	D10-7100	FDA UDI	Class I	Active
Urinals (child) Slipper	DJ4914	FDA UDI	Class I	Active
LID FOR CRIMPED WIRE MESH BASKETS (DETENTION FRAME) 480x250MM	DJ4461DTCW	FDA UDI	Class I	Active
LID FOR STANDARD WIRE MESH BASKETS (SINGLE FRAME) 405x250MM	DJ4459	FDA UDI	Class I	Active
SPRI BASKETS (Single Frame), 600x300x100 MM	DJ6032	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 480x250x50MM	DJ4432ER	FDA UDI	Class I	Active
CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 105x245x50MM	DJ4476CW	FDA UDI	Class I	Active
Harms-Colibri Forceps Del 0.12mm	D50-1902	EUDAMEDFDA UDI	Class I	Active
MICRO OPHTHALMIC BASKETS, 400x250x38	DJ9022002	FDA UDI	Class I	Active
DIN BASKET SIDE PERFORTED WOVEN BASE WIRE, 405x250x70MM	DJ4659	FDA UDI	Class I	Active
Lieberman Aspir Spec V-Wire 15mm	D10-5175	FDA UDI	Class I	Active
Castroveijo Speculum 16mm Blade	D10-5703	FDA UDI	Class I	Active
Capsulorrhexis Forceps 11mm Angled	D50-700003	EUDAMEDFDA UDI	Class I	Active
Endoscope Baskets, 310x150x77	DJ4054	FDA UDI	Class I	Active
CLASSIC CRIMPED WIRE MESH BASKETS WITH TILTED HANDLES 105x240MM	DJ4455DTCW	FDA UDI	Class I	Active
LID FOR PERFORATED BASKET (DOUBLE FRAME) 480x360MM	DJ4587	FDA UDI	Class I	Active

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