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	BF.408.090	EUDAMED	Class I	Active
Falcon	DR.121.011F	EUDAMED	Class I	Active
Falcon	DE.700.742	EUDAMED	Class I	Active
Falcon	BS.655.155	EUDAMED	Class I	Active
Falcon	DS.571.130	EUDAMED	Class I	Active
Falcon	DR.525.017	EUDAMED	Class I	Active
Falcon	BS.654.130	EUDAMED	Class I	Active
Falcon	DE.471.505	EUDAMED	Class I	Active
Falcon	DE.086.012	EUDAMED	Class I	Active
Unodent	DEE179	EUDAMED	Class I	Active
Falcon	BP.070.130	EUDAMED	Class I	Active
Unodent	BXS025	EUDAMED	Class I	Active
Unodent	DEE131	EUDAMED	Class I	Active
Falcon	DS.416.011	EUDAMED	Class I	Active
Falcon	DR.090.015	EUDAMED	Class I	Active
Falcon	DD.420.121	EUDAMED	Class I	Active
Falcon	DI.725.060	EUDAMED	Class I	Active
Falcon	DP.375.095X	EUDAMED	Class I	Active
Falcon	DD.528.110	EUDAMED	Class I	Active
Falcon	DS.872.045	EUDAMED	Class I	Active
Falcon	DR.602.027	EUDAMED	Class I	Active
Falcon	BG.470.155	EUDAMED	Class I	Active
Falcon	DR.119.047	EUDAMED	Class I	Active
Apex	2S905001	EUDAMED	Class I	Active
Falcon	DR.089.040	EUDAMED	Class I	Active
Unodent	DEN156	EUDAMED	Class I	Active
Falcon	DR.090.040	EUDAMED	Class I	Active
Falcon	DP.148.165	EUDAMED	Class I	Active
Falcon	DO.565.300	EUDAMED	Class I	Active
Apex	2S528020	EUDAMED	Class I	Active
Falcon	DE.025.030	EUDAMED	Class I	Active
Apex	2S160021	EUDAMED	Class I	Active
Falcon	DZ.425.040	EUDAMED	Class I	Active
Falcon	BR.474.000	EUDAMED	Class I	Active
Falcon	DO.877.300	EUDAMED	Class I	Active
Falcon	DP.774.527	EUDAMED	Class I	Active
Falcon	DR.089.017	EUDAMED	Class I	Active
Falcon	DO.206.022	EUDAMED	Class I	Active
Falcon	DR.235.025	EUDAMED	Class I	Active
Falcon	DI.004.025	EUDAMED	Class I	Active
Falcon	DS.125.050	EUDAMED	Class I	Active
Apex	2S01229	EUDAMED	Class I	Active
Falcon	DR.048.547	EUDAMED	Class I	Active
Apex	2SEKO450500	EUDAMED	Class I	Active
Falcon	BD.372.120	EUDAMED	Class I	Active
Falcon	DD.157.506	EUDAMED	Class I	Active
Falcon	DO.546.500	EUDAMED	Class I	Active
Falcon	BQ.814.030	EUDAMED	Class I	Active
Falcon	DD.150.170	EUDAMED	Class I	Active
Falcon	BQ.206.040	EUDAMED	Class I	Active

Falcon Surgical Co. (Pvt.) Ltd

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