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	2S01650	EUDAMED	Class I	Active
Falcon	DR.440.497	EUDAMED	Class I	Active
Falcon	DR.279.010	EUDAMED	Class I	Active
Falcon	DA.721.180	EUDAMED	Class I	Active
Falcon	BD.230.145	EUDAMED	Class I	Active
Falcon	DS.872.065	EUDAMED	Class I	Active
Essential	ORTE-DO-240-010	EUDAMED	Class I	Active
Falcon	DR.594.027	EUDAMED	Class I	Active
Falcon	DP.142.035	EUDAMED	Class I	Active
Falcon	DR.584.230P	EUDAMED	Class I	Active
Falcon	BQ.928.025	EUDAMED	Class I	Active
Falcon	DR.130.030	EUDAMED	Class I	Active
Falcon	DI.330.020	EUDAMED	Class I	Active
Falcon	DE.300.104	EUDAMED	Class I	Active
Falcon	DR.270.010	EUDAMED	Class I	Active
Falcon	BG.560.200	EUDAMED	Class I	Active
Falcon	DP.763.021	EUDAMED	Class I	Active
Falcon	BH.246.140	EUDAMED	Class I	Active
Falcon	BA.284.200	EUDAMED	Class I	Active
Falcon	DS.845.015T	EUDAMED	Class I	Active
Falcon	DP.160.167	EUDAMED	Class I	Active
Falcon	SS.574.030	EUDAMED	Class I	Active
Falcon	BD.280.200	EUDAMED	Class I	Active
Falcon	DS.901.142	EUDAMED	Class I	Active
Falcon	BS.119.115	EUDAMED	Class I	Active
Falcon	BN.383.130	EUDAMED	Class I	Active
Falcon	DP.860.517	EUDAMED	Class I	Active
Falcon	DR.555.002	EUDAMED	Class I	Active
Falcon	DZ.430.030S	EUDAMED	Class I	Active
Falcon	DE.710.861	EUDAMED	Class I	Active
Falcon	DD.532.080	EUDAMED	Class I	Active
Falcon	DR.840.030	EUDAMED	Class I	Active
Falcon	DO.395.140	EUDAMED	Class I	Active
Falcon	BQ.753.030	EUDAMED	Class I	Active
Falcon	DR.428.017P	EUDAMED	Class I	Active
Falcon	BN.298.200	EUDAMED	Class I	Active
Falcon	DR.587.040	EUDAMED	Class I	Active
Falcon	DR.906.130	EUDAMED	Class I	Active
Falcon	DD.101.112	EUDAMED	Class I	Active
Unodent	IIU200	EUDAMED	Class I	Active
Falcon	BM.420.150	EUDAMED	Class I	Active
Falcon	DD.201.070P	EUDAMED	Class I	Active
Falcon	BK.657.040	EUDAMED	Class I	Active
Falcon	BQ.716.020	EUDAMED	Class I	Active
Falcon	DE.925.040	EUDAMED	Class I	Active
Falcon	DE.720.767	EUDAMED	Class I	Active
Falcon	BS.880.115	EUDAMED	Class I	Active
Falcon	FB.085.190	EUDAMED	Class I	Active
Falcon	BH.669.130	EUDAMED	Class I	Active
Falcon	BQ.321.220	EUDAMED	Class I	Active

Falcon Surgical Co. (Pvt.) Ltd

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