Question 1

What types of medical devices does Bonetech Medisys Pvt. Ltd. manufacture?

Accepted Answer

Bonetech Medisys Pvt. Ltd. specializes in orthopedic trauma fixation devices. Their portfolio includes intramedullary nails (like the TRAUMEX series) for stabilizing long bone fractures, spinal fixation systems (such as RTHROX), and emergency spinal stabilization tools (like NEXPINE). These devices are designed to aid in fracture stabilization and surgical interventions.

Question 2

Where is Bonetech Medisys Pvt. Ltd. based?

Accepted Answer

The company is headquartered in India. This geographic location reflects its focus on manufacturing and supplying orthopedic trauma fixation devices globally, including those listed in regulatory databases like EUDAMED.

Question 3

Which regulatory registries list Bonetech Medisys Pvt. Ltd.’s devices?

Accepted Answer

Bonetech Medisys Pvt. Ltd.’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for device classification and traceability.

Question 4

How are Bonetech Medisys Pvt. Ltd.’s devices classified under EU regulations?

Accepted Answer

All of Bonetech Medisys Pvt. Ltd.’s listed devices fall under Class IIb classification in the EU. This classification applies to devices that pose moderate risks and require additional scrutiny, such as orthopedic fixation systems, to ensure their safety and performance.

Device	Model / Reference	Registries	Class	Status
Traumex	BT356.T06R	EUDAMED	Class IIb	Active
Intrex	BN101.T60.26	EUDAMED	Class IIb	Active
Traumex	BT110.T45	EUDAMED	Class IIb	Active
Intrex	BN101.S60.18	EUDAMED	Class IIb	Active
Nexpine	BS105.55.30	EUDAMED	Class IIb	Active
Intrex	BN102.T09.34	EUDAMED	Class IIb	Active
Traumex	BT110.T28	EUDAMED	Class IIb	Active
Traumex	BT507.S06	EUDAMED	Class IIb	Active
Traumex	BT104.T95	EUDAMED	Class IIb	Active
Traumex	BT507.T07	EUDAMED	Class IIb	Active
Traumex	BT106.T52	EUDAMED	Class IIb	Active
Traumex	BT353.T15R	EUDAMED	Class IIb	Active
Traumex	BT108.T80	EUDAMED	Class IIb	Active
Traumex	BT306.T05L	EUDAMED	Class IIb	Active
Traumex	BT501.T07	EUDAMED	Class IIb	Active
Traumex	BT109.T60	EUDAMED	Class IIb	Active
Traumex	BT104.T22	EUDAMED	Class IIb	Active
Traumex	BT506.S16	EUDAMED	Class IIb	Active
Traumex	BT104.T18	EUDAMED	Class IIb	Active
Nexpine	BS106.65.75	EUDAMED	Class IIb	Active
Traumex	BT104.T30	EUDAMED	Class IIb	Active
Intrex	BN102.T09.32	EUDAMED	Class IIb	Active
Intrex	BN101.S60.28	EUDAMED	Class IIb	Active
Traumex	BT353.T05R	EUDAMED	Class IIb	Active
Traumex	BT350.T11R	EUDAMED	Class IIb	Active
Traumex	BT108.T30	EUDAMED	Class IIb	Active
Traumex	BT308.T09R	EUDAMED	Class IIb	Active
Rthrox	BA104.10.20	EUDAMED	Class IIb	Active
Intrex	BN101.T60.30	EUDAMED	Class IIb	Active
Traumex	BT312.T07L	EUDAMED	Class IIb	Active
Intrex	BN104.T11.44	EUDAMED	Class IIb	Active
Traumex	BT110.T50	EUDAMED	Class IIb	Active
Rthrox	BA104.11.25	EUDAMED	Class IIb	Active
Traumex	BT109.T35	EUDAMED	Class IIb	Active
Traumex	BT110.T26	EUDAMED	Class IIb	Active
Nexpine	BS103.65.45	EUDAMED	Class IIb	Active
Intrex	BN104.T11.38	EUDAMED	Class IIb	Active
Rthrox	BA111.30	EUDAMED	Class IIb	Active
Nexpine	BS104.45.30	EUDAMED	Class IIb	Active
Traumex	BT104.T40	EUDAMED	Class IIb	Active
Nexpine	BS106.65.60	EUDAMED	Class IIb	Active
Traumex	BT110.T55	EUDAMED	Class IIb	Active
Intrex	BN105.T09.34	EUDAMED	Class IIb	Active
Rthrox	BA102.11.25	EUDAMED	Class IIb	Active
Intrex	BN104.T10.42	EUDAMED	Class IIb	Active
Traumex	BT102.T28	EUDAMED	Class IIb	Active
Traumex	BT202.T07	EUDAMED	Class IIb	Active
Nexpine	BS134.70.70	EUDAMED	Class IIb	Active
Traumex	BT310.T11L	EUDAMED	Class IIb	Active
Intrex	BN102.T08.38	EUDAMED	Class IIb	Active

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