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	4000025525-S	EUDAMED	Class IIb	Active
Venus	1004101600	EUDAMED	Class I	Active
VENUSnano	2200010203	EUDAMED	Class I	Active
Venus	1016100000	EUDAMED	Class I	Active
Venus	1001010408-5	EUDAMED	Class I	Active
Tristan	1502010037	EUDAMED	Class I	Active
Hero	1101010600	EUDAMED	Class I	Active
Venus	1001012002	EUDAMED	Class I	Active
Samson	2000050000	EUDAMED	Class I	Active
Venus	1008010600	EUDAMED	Class I	Active
Venus	1008010207-5	EUDAMED	Class I	Active
Adonis	1701010201	EUDAMED	Class I	Active
Venus	1006010811	EUDAMED	Class I	Active
Venus	1001010408	EUDAMED	Class I	Active
Venus	55279	EUDAMED	Class I	Active
Venus	1006010701	EUDAMED	Class I	Active
Venus	1001010408-3	EUDAMED	Class I	Active
VENUSnano	2200010100	EUDAMED	Class I	Active
Venus	1008010207	EUDAMED	Class I	Active
Samson	2000050000-B	EUDAMED	Class I	Active
Venus	4008020101	EUDAMED	Class I	Active
Tristan	1501010500	EUDAMED	Class I	Active
Adonis	2001010300	EUDAMED	Class I	Active
Venus	4008010104	EUDAMED	Class I	Active
Adonis	1701010600	EUDAMED	Class I	Active
Venus	1004101601	EUDAMED	Class I	Active
VENUSnano	2200010018	EUDAMED	Class I	Active
Venus	4008020006	EUDAMED	Class I	Active
VENUSnano	2200010101	EUDAMED	Class I	Active
Disc Evacuation Set	1901010305	EUDAMED	Class I	Active
Venus	55104	EUDAMED	Class I	Active
VENUSnano	2200010054	EUDAMED	Class I	Active
Venus	4008010008	EUDAMED	Class I	Active
Hero	1101010006	EUDAMED	Class I	Active
Hero	1101010100	EUDAMED	Class I	Active
Adonis	1801010004	EUDAMED	Class I	Active
Venus	4008010102	EUDAMED	Class I	Active
Tristan	1501010003	EUDAMED	Class I	Active
Venus	1006010711	EUDAMED	Class I	Active
Venus	1001010401	EUDAMED	Class I	Active
Venus	1001010408-1	EUDAMED	Class I	Active
Venus	1001010057	EUDAMED	Class I	Active
Disc Evacuation Set	1901010304	EUDAMED	Class I	Active
Venus	1001055085	EUDAMED	Class I	Active
Hero	1101010011	EUDAMED	Class I	Active
Venus	1006010600	EUDAMED	Class I	Active
Hero	1101010200	EUDAMED	Class I	Active
Samson	2000040000-4	EUDAMED	Class I	Active
Venus	4008010005	EUDAMED	Class I	Active
Disc Evacuation Set	1901010306	EUDAMED	Class I	Active

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