Question 1

What types of medical devices does Artified International manufacture?

Accepted Answer

Artified International specialises in surgical instruments, including forceps (such as Vulsellum and Uterine Polypus types), scissors, towel clamps, needle holders, wire cutters, and dressing forceps. These devices are designed for precision in surgical, dental, and diagnostic procedures, ensuring reliability and safety in clinical settings.

Question 2

Where is Artified International based?

Accepted Answer

Artified International is headquartered in Pakistan. The company’s global manufacturing focus allows it to supply high-quality instruments internationally, including within the European market.

Question 3

Which regulatory registries list Artified International’s devices?

Accepted Answer

Artified International’s devices are registered in the EUDAMED database, which is the European Union’s centralised system for tracking medical devices. This registration is required for compliance with EU regulations, particularly for devices classified under the applicable framework.

Question 4

How are Artified International’s devices classified under EU regulations?

Accepted Answer

All of Artified International’s listed devices fall under EU Class I classification. This classification applies to low-risk instruments like forceps, scissors, and clamps, which typically require less stringent regulatory oversight compared to higher-risk devices. Classification is determined by factors such as the device’s intended use and potential health risks.

Device	Model / Reference	Registries	Class	Status
Vulsellum Forceps	A-SI-6152	EUDAMED	Class I	Active
Uterine Polypus Forceps	A-SI-6174	EUDAMED	Class I	Active
Utility Scissors	A-PS-4001	EUDAMED	Class I	Active
Wire Cutters	A-SI-6569	EUDAMED	Class I	Active
Forceps	A-SI-3993	EUDAMED	Class I	Active
Clamp Forceps	A-SI-4009	EUDAMED	Class I	Active
Dressing Forceps – Tweezers Like	A-SI-3594	EUDAMED	Class I	Active
Scissors	A-SI-3076A	EUDAMED	Class I	Active
Towel Clamps	A-SI-4157	EUDAMED	Class I	Active
Needle Holder	A-SI-5320	EUDAMED	Class I	Active
Scissors	A-SI-3076	EUDAMED	Class I	Active
Clamp Forceps	A-SI-5598	EUDAMED	Class I	Active
Sponge Holder	A-SI-4187	EUDAMED	Class I	Active
Catheter Introducing Forceps	01-2076	EUDAMED	Class I	Active
Nasal Specula	A-SI-6474	EUDAMED	Class I	Active
Forceps	A-SI-3997	EUDAMED	Class I	Active
Suture Instruments Like Tweezers	A-SI-5399	EUDAMED	Class I	Active
Towel Forceps	A-SI-4160	EUDAMED	Class I	Active
Scissors (Non-Surgical)	A-SI-3188	EUDAMED	Class I	Active
Tampon Force	A-SI-6483	EUDAMED	Class I	Active
Plastic Surgery Scissors	A-SI-3350	EUDAMED	Class I	Active
Ear Forceps	A-SI-6454	EUDAMED	Class I	Active
Diagnostic Hammer	A-SI-3006	EUDAMED	Class I	Active
Needle Holder	A-SI-5319	EUDAMED	Class I	Active
Instruments Trays	07-9444	EUDAMED	Class I	Active
Dressing Forceps – Scissors Like	A-SI-4195	EUDAMED	Class I	Active
Forceps	A-SI-4170	EUDAMED	Class I	Active
Ligature Scissors	A-SI-3427	EUDAMED	Class I	Active
Instruments Trays	07-9450	EUDAMED	Class I	Active
Needle Holder	A-SI-5035	EUDAMED	Class I	Active
Towel Clamps	A-SI-4168	EUDAMED	Class I	Active
Catheter Introducing Forceps	01-2075	EUDAMED	Class I	Active
Tonsil Scissors	A-SI-3379	EUDAMED	Class I	Active
Bandage Scissors	02-3265	EUDAMED	Class I	Active

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