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	BT106.T58	EUDAMED	Class IIb	Active
Traumex	BT109.T45	EUDAMED	Class IIb	Active
Traumex	BT203.T10	EUDAMED	Class IIb	Active
Traumex	BT108.T25	EUDAMED	Class IIb	Active
Nexpine	BS103.65.50	EUDAMED	Class IIb	Active
Rthrox	BA102.09.25	EUDAMED	Class IIb	Active
Traumex	BT352.T11	EUDAMED	Class IIb	Active
Traumex	BT104.T24	EUDAMED	Class IIb	Active
Traumex	BT104.T38	EUDAMED	Class IIb	Active
Rthrox	BA102.07.30	EUDAMED	Class IIb	Active
Traumex	BT203.T07	EUDAMED	Class IIb	Active
Rthrox	BA102.10.20	EUDAMED	Class IIb	Active
Nexpine	BS105.55.35	EUDAMED	Class IIb	Active
Intrex	BN104.T10.32	EUDAMED	Class IIb	Active
Nexpine	BS134.70.40	EUDAMED	Class IIb	Active
Intrex	BN104.T10.40	EUDAMED	Class IIb	Active
Traumex	BT308.T05L	EUDAMED	Class IIb	Active
G562bt109t240	BT109.T24	EUDAMED	Class IIb	Active
Nexpine	BS105.55.40	EUDAMED	Class IIb	Active
Rthrox	BA114.35	EUDAMED	Class IIb	Active
Rthrox	BA114.40	EUDAMED	Class IIb	Active
Nexpine	BS104.45.35	EUDAMED	Class IIb	Active
Inrtex	BN101.T60.24	EUDAMED	Class IIb	Active
Traumex	BT205.T10	EUDAMED	Class IIb	Active
Intrex	BN104.T10.36	EUDAMED	Class IIb	Active
Traumex	BT307.T05L	EUDAMED	Class IIb	Active
Traumex	BT108.T70	EUDAMED	Class IIb	Active
Traumex	BT102.T26	EUDAMED	Class IIb	Active
Nexpine	BS102.55.30	EUDAMED	Class IIb	Active
Traumex	BT507.T09	EUDAMED	Class IIb	Active
Nexpine	BS101.45.30	EUDAMED	Class IIb	Active
Intrex	BN104.T12.36	EUDAMED	Class IIb	Active
Traumex	BT102.T18	EUDAMED	Class IIb	Active
Traumex	BT110.T35	EUDAMED	Class IIb	Active
Traumex	BT104.T75	EUDAMED	Class IIb	Active
Traumex	BT509.S10	EUDAMED	Class IIb	Active
Traumex	BT102.T50	EUDAMED	Class IIb	Active
Traumex	BT265.T02R	EUDAMED	Class IIb	Active
Traumex	BT104.T55	EUDAMED	Class IIb	Active
Intrex	BN104.T09.42	EUDAMED	Class IIb	Active
Nexpine	BS106.65.70	EUDAMED	Class IIb	Active
Traumex	BT202.T14	EUDAMED	Class IIb	Active
Intrex	BN101.T75.28	EUDAMED	Class IIb	Active
Intrex	BN105.T09.38	EUDAMED	Class IIb	Active
Traumex	BT106.T48	EUDAMED	Class IIb	Active
Traumex	BT104.T85	EUDAMED	Class IIb	Active
Traumex	BT110.T75	EUDAMED	Class IIb	Active
Rthrox	BA106.20	EUDAMED	Class IIb	Active
Intrex	BN102.T08.36	EUDAMED	Class IIb	Active
Traumex	BT205.T08	EUDAMED	Class IIb	Active

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