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
Falcon	BH.271.145	EUDAMED	Class I	Active
Falcon	DO.241.020	EUDAMED	Class I	Active
Falcon	DP.895.057	EUDAMED	Class I	Active
Falcon	DP.792.335	EUDAMED	Class I	Active
Falcon	DD.304.230	EUDAMED	Class I	Active
Falcon	DR.135.551	EUDAMED	Class I	Active
Unodent	DFO211	EUDAMED	Class I	Active
Falcon	DP.895.085X	EUDAMED	Class I	Active
Falcon	DE.730.331	EUDAMED	Class I	Active
Falcon	DP.947.137	EUDAMED	Class I	Active
Falcon	DS.903.030	EUDAMED	Class I	Active
Apex	2S0P1791	EUDAMED	Class I	Active
Falcon	DI.765.040	EUDAMED	Class I	Active
Essential	EKO90025	EUDAMED	Class I	Active
Unodent	DSC352	EUDAMED	Class I	Active
Unodent	DUD006	EUDAMED	Class I	Active
Unodent	COX010	EUDAMED	Class I	Active
Falcon	DI.800.030	EUDAMED	Class I	Active
Falcon	DR.460.050	EUDAMED	Class I	Active
Falcon	DR.980.080	EUDAMED	Class I	Active
Unodent	EWF250	EUDAMED	Class I	Active
Falcon	BK.656.040	EUDAMED	Class I	Active
Falcon	DR.615.127	EUDAMED	Class I	Active
Falcon	DD.457.235P	EUDAMED	Class I	Active
Falcon	DR.092.020	EUDAMED	Class I	Active
Falcon	DS.210.121	EUDAMED	Class I	Active
Falcon	DR.452.010T	EUDAMED	Class I	Active
Falcon	BK.150.120	EUDAMED	Class I	Active
Falcon	DE.900.020	EUDAMED	Class I	Active
Falcon	DR.906.212	EUDAMED	Class I	Active
Apex	2S01988	EUDAMED	Class I	Active
Falcon	SS.857.240	EUDAMED	Class I	Active
Falcon	BH.671.200	EUDAMED	Class I	Active
Unodent	DFO437	EUDAMED	Class I	Active
Falcon	DR.960.031	EUDAMED	Class I	Active
Falcon	DE.930.060	EUDAMED	Class I	Active
Falcon	DE.720.240	EUDAMED	Class I	Active
Falcon	BN.700.120	EUDAMED	Class I	Active
AZ-Orthodontics	IHS-MHR	EUDAMED	Class I	Active
Falcon	DE.450.057	EUDAMED	Class I	Active
Falcon	DP.940.157	EUDAMED	Class I	Active
Falcon	DR.148.047P	EUDAMED	Class I	Active

Falcon Surgical Co. (Pvt.) Ltd

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