Question 1

What types of medical devices does Falcon Surgical Co. (Pvt.) Ltd manufacture?

Accepted Answer

Falcon Surgical Co. (Pvt.) Ltd specializes in dental and surgical instruments. Their product line includes the Unodent series, which appears tailored for oral surgical procedures, as well as the Falcon series, a range of general surgical tools. Additionally, they produce the Apex device, likely designed for endodontic applications such as root canal treatments. These devices are engineered for precision in clinical settings.

Question 2

Where is Falcon Surgical Co. (Pvt.) Ltd based?

Accepted Answer

Falcon Surgical Co. (Pvt.) Ltd is headquartered in Pakistan. The company’s location influences its regulatory compliance requirements, particularly for markets like the EU where devices must meet specific standards.

Question 3

Which regulatory registries list Falcon Surgical Co. (Pvt.) Ltd’s devices?

Accepted Answer

Falcon Surgical Co. (Pvt.) Ltd’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements for Class I devices.

Question 4

How are Falcon Surgical Co. (Pvt.) Ltd’s devices classified under medical device regulations?

Accepted Answer

Falcon Surgical Co. (Pvt.) Ltd’s devices fall under Class I classification. This classification is assigned based on risk assessment criteria, where Class I devices are considered low-risk and typically pose minimal risk to patients. The classification determines the regulatory pathway and compliance requirements for market authorization.

Device	Model / Reference	Registries	Class	Status
Apex	2S425021	EUDAMED	Class I	Active
Essential	ORTE-DO-160-000	EUDAMED	Class I	Active
Falcon	DA.791.180	EUDAMED	Class I	Active
Falcon	DZ.085.029	EUDAMED	Class I	Active
Falcon	DO.160.000	EUDAMED	Class I	Active
Falcon	DD.910.050	EUDAMED	Class I	Active
Falcon	DD.420.211	EUDAMED	Class I	Active
Falcon	FC.920.180	EUDAMED	Class I	Active
Falcon	DE.720.791	EUDAMED	Class I	Active
Falcon	DD.980.130	EUDAMED	Class I	Active
Falcon	DP.895.075	EUDAMED	Class I	Active
Apex	2S02165	EUDAMED	Class I	Active
Falcon	BH.350.030	EUDAMED	Class I	Active
Falcon	DD.945.030	EUDAMED	Class I	Active
Falcon	BQ.936.065	EUDAMED	Class I	Active
Falcon	DR.095.010	EUDAMED	Class I	Active
Falcon	DD.996.230	EUDAMED	Class I	Active
Falcon	DI.711.050	EUDAMED	Class I	Active
Falcon	DP.392.097P	EUDAMED	Class I	Active
Falcon	DP.152.125	EUDAMED	Class I	Active
Falcon	DR.139.037	EUDAMED	Class I	Active
Falcon	DR.873.017	EUDAMED	Class I	Active
Falcon	BD.780.310	EUDAMED	Class I	Active
Apex	2S01882	EUDAMED	Class I	Active
Falcon	BH.941.200	EUDAMED	Class I	Active
Falcon	DI.005.014	EUDAMED	Class I	Active
Falcon	FB.746.165	EUDAMED	Class I	Active
Falcon	DP.764.024	EUDAMED	Class I	Active
Falcon	DR.400.011	EUDAMED	Class I	Active
Falcon	DR.068.030	EUDAMED	Class I	Active
Falcon	DP.156.185	EUDAMED	Class I	Active
Falcon	DI.760.020	EUDAMED	Class I	Active
Falcon	DZ.085.010	EUDAMED	Class I	Active
Falcon	DE.300.850	EUDAMED	Class I	Active
Falcon	DR.371.047	EUDAMED	Class I	Active
Falcon	BD.990.130	EUDAMED	Class I	Active
Falcon	DR.458.041	EUDAMED	Class I	Active
Apex	2S01806	EUDAMED	Class I	Active
Falcon	DS.274.010	EUDAMED	Class I	Active
Falcon	DD.996.061	EUDAMED	Class I	Active
Falcon	BP.300.130	EUDAMED	Class I	Active
Falcon	DE.910.360T	EUDAMED	Class I	Active
Falcon	DE.086.032	EUDAMED	Class I	Active
Essential	ORTE-DD-470-031	EUDAMED	Class I	Active
Falcon	DR.428.077P	EUDAMED	Class I	Active
Falcon	DE.400.167	EUDAMED	Class I	Active
Falcon	DD.304.170	EUDAMED	Class I	Active
Unodent	DEN360	EUDAMED	Class I	Active
Apex	2S092102	EUDAMED	Class I	Active
Falcon	SS.572.050	EUDAMED	Class I	Active

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