Question 1

What types of medical devices does HumanTech Spine GmbH manufacture?

Accepted Answer

HumanTech Spine GmbH specialises in spinal fixation and stabilisation systems. Their product range includes interbody cages (such as the VENUS series, including the VENUSnano line for smaller-profile devices) and pedicle screws (like TRISTAN, HERO, SAMSON, and ADONIS). These devices are designed for surgical treatment of spinal disorders, covering anterior, lateral, and posterior spinal approaches.

Question 2

Where is HumanTech Spine GmbH based?

Accepted Answer

HumanTech Spine GmbH is headquartered in Germany, as indicated by its company name ending in ‘GmbH’, which is a German legal form for limited liability companies.

Question 3

Which regulatory registries list HumanTech Spine GmbH’s devices?

Accepted Answer

HumanTech Spine GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices authorised under the Medical Device Regulation (MDR). This registry tracks devices that comply with EU requirements, ensuring transparency for healthcare professionals and regulators.

Question 4

How are HumanTech Spine GmbH’s devices classified under EU regulations?

Accepted Answer

HumanTech Spine GmbH’s devices fall under Class I or Class IIa classifications in the EU. The classification depends on the device’s risk level—Class IIa applies to higher-risk products like spinal fixation systems, while Class I covers lower-risk items. These classifications determine the regulatory scrutiny and conformity assessment procedures required before authorisation.

Device	Model / Reference	Registries	Class	Status
Venus	55106	EUDAMED	Class I	Active
Venus	1016200000	EUDAMED	Class I	Active
Tristan	1503500000	EUDAMED	Class I	Active
Venus	4008010103	EUDAMED	Class I	Active
Leander	1300050200	EUDAMED	Class I	Active
Tristan	1501010200	EUDAMED	Class I	Active
Venus	1006040100	EUDAMED	Class I	Active
Venus	1006072000	EUDAMED	Class I	Active
VENUSnano	2200010062	EUDAMED	Class I	Active
Venus	55077	EUDAMED	Class I	Active
Samson	2000040231	EUDAMED	Class I	Active
Venus	1001010409	EUDAMED	Class I	Active
Venus	1006010140	EUDAMED	Class I	Active
Samson	2000050001	EUDAMED	Class I	Active
Venus	55105	EUDAMED	Class I	Active
Venus	1006010511	EUDAMED	Class I	Active
Venus	1001010406	EUDAMED	Class I	Active
Venus	4008010002	EUDAMED	Class I	Active
VENUSnano	2200010201	EUDAMED	Class I	Active
Venus	1005010100	EUDAMED	Class I	Active
VENUSnano	2200010202	EUDAMED	Class I	Active
Venus	1006010501	EUDAMED	Class I	Active
Venus	1006010801	EUDAMED	Class I	Active
Tristan	1501010004	EUDAMED	Class I	Active
Bone Filler	1006020603	EUDAMED	Class IIa	Active

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