Question 1

What types of medical devices does FHQ Trading CO. manufacture?

Accepted Answer

FHQ Trading CO. specializes in dental surgical instruments. Their portfolio includes forceps like the Castroviejo, Wullstein, and Reynolds, as well as periodontal instruments and amalgam tools. They also produce specialized tools such as the Sinus Lift Instrument, Lambotte, Frazier, and extracting forceps (American Pattern), along with tissue-handling instruments like the Adson-Tc Forcep and Babcock. These devices are designed for precision in dental procedures.

Question 2

Where is FHQ Trading CO. based?

Accepted Answer

FHQ Trading CO. is based in Pakistan. While their headquarters is located there, their instruments are intended for use in dental surgical settings globally, including within the European Union.

Question 3

Which regulatory registries list FHQ Trading CO.’s devices?

Accepted Answer

FHQ Trading CO.’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under the European Medical Device Regulation (MDR). This registration applies to their instruments, which are classified as Class I devices.

Question 4

How are FHQ Trading CO.’s devices classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulation (MDR), FHQ Trading CO.’s instruments are classified as Class I devices. This classification is determined based on their intended use—specifically, their role in dental surgical procedures—and their risk profile, which is deemed low enough to warrant this regulatory category.

Device	Model / Reference	Registries	Class	Status
Castroviejo	10-306-14-07	EUDAMED	Class I	Active
Wullstein	19-005-51-14	EUDAMED	Class I	Active
Reynolds	02-364-14-07	EUDAMED	Class I	Active
Amalgam Instruments	FHQ-1580	EUDAMED	Class I	Active
Lempert	19-737-20-07	EUDAMED	Class I	Active
Periodontal Instruments	FHQ-1679	EUDAMED	Class I	Active
EXTRACTING FORCEPS (American Pattern)	FHQ-163	EUDAMED	Class I	Active
Frazier	08-522-10-01	EUDAMED	Class I	Active
Lambotte	12-139-04-07	EUDAMED	Class I	Active
Sinus Lift Instrument	FHQ-2148	EUDAMED	Class I	Active
Adson-Tc Forcep	FHQ-668	EUDAMED	Class I	Active
Babcock	14-192-16-07	EUDAMED	Class I	Active
Wangen Holder	FHQ-1257	EUDAMED	Class I	Active
operating scissor	02-105-02-07	EUDAMED	Class I	Active
Crile-Wood needle holder	10-350-15-07	EUDAMED	Class I	Active
Castroviejo calliper	18-133-06-07	EUDAMED	Class I	Active
Explorers	FHQ-724	EUDAMED	Class I	Active
Pean Forcep	04-374-04-07	EUDAMED	Class I	Active
Ortho light scaler double ended	FHQ-1864	EUDAMED	Class I	Active
kidney tray	22-321-23-01	EUDAMED	Class I	Active
Adson Forcep	03-369-03-07	EUDAMED	Class I	Active
Adams Orthodontic Plier	FHQ-1895	EUDAMED	Class I	Active
Simpson	17-145-30-07	EUDAMED	Class I	Active
Hard wire Orthodontic Plier	FHQ-1928	EUDAMED	Class I	Active
Ferris-Smith-Kerrison	20-356-17-07	EUDAMED	Class I	Active
EXTRACTING FORCEPS (English Pattern)	FHQ-011	EUDAMED	Class I	Active
Magill forcep	09-301-15-07	EUDAMED	Class I	Active
Farabeuf	06-665-00-07	EUDAMED	Class I	Active
Dissecting Knives fig. 1	01-002-01-07	EUDAMED	Class I	Active
Varady	07-249-01-07	EUDAMED	Class I	Active
Chompret root elevator	FHQ-483	EUDAMED	Class I	Active
Dental Syringes	FHQ-232	EUDAMED	Class I	Active
Förster sponge forcep	05-350-25-07	EUDAMED	Class I	Active
Jackson	13-155-17-07	EUDAMED	Class I	Active
Millin	15-463-23-07	EUDAMED	Class I	Active
Filling Instruments	FHQ-939	EUDAMED	Class I	Active
Cusco speculum	16-114-02-01	EUDAMED	Class I	Active
Kristeller	16-190-01-01	EUDAMED	Class I	Active
Root Elevator	FHQ-328	EUDAMED	Class I	Active
Weitlaner	06-750-13-07	EUDAMED	Class I	Active
Beyer	12-879-18-07	EUDAMED	Class I	Active
Henke	21-289-23-07	EUDAMED	Class I	Active

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