BionIT Labs S.r.l.
Italy IT-MF-000007793 Last updated 25 Oct 2026
- Devices
- 358
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Adam's Hand Plus Ref AH03-RS1-A0-01
Adam's Skin Plus Ref AS03-RS1-N7
Adam's Hand Plus Ref AH03-RS1-B1-01-L
Adam's Hand Plus Ref AH03-LS1-N2-01
Adam's Skin Plus Ref AS03-LS1-N6
Adam's Hand Plus Ref AH03-RS1-N7-01
Adam's Hand Plus Ref AH03-LS1-A0-01
Adam's Hand Plus Ref AH03-LS1-W1-01-L
Adam's Skin Plus Ref AS03-RS1-N8
Adam's Hand Plus Ref AH03-LS1-B1-01-L
Adam's Hand Plus Ref AH03-RS1-N6-01
Adam's Skin Plus Ref AS03-LS1-N7
PRISM Hub Ref PRH01-01
Adam's Hand Plus Ref AH03-RS1-N4-01
Adam's Skin Plus Ref AS03-LS1-N2
Adam's Skin Plus Ref AS03-RS1-N1
Adam's Skin Plus Ref AS03-LS1-A0
Adam's Hand Plus Ref AH03-LS1-N6-01
Adam's Skin Plus Ref AS03-LS1-N3
Adam's Skin Plus Ref AS03-LS1-I0
Adam's Skin Plus Ref AS03-LS1-N5
Adam's Hand Plus Ref AH03-LS1-N5-01
Adam's Skin Plus Ref AS03-RS1-A0
Adam's Skin Plus Ref AS03-RS1-N2
Adam's Hand Plus Ref AH03-LS1-N1-01
Adam's Hand Plus Ref AH03-LS1-N8-01
Adam's Skin Plus Ref AS03-LS1-W1
Adam's Hand Plus Ref AH03-LS1-B1-01-D
Adam's Hand Plus Ref AH03-LS1-N7-01
Adam's Hand Plus Ref AH03-LS1-N3-01
Adam's Hand Plus Ref AH03-RS1-N3-01
Adam's Skin Plus Ref AS03-RS1-N4
Adam's Skin Plus Ref AS03-LS1-N1
Adam's Hand Plus Ref AH03-RS1-I0-01
Pulse Hub Ref VFH01
Adam's Hand Plus Ref AH03-LS1-N4-01
Adam's Skin Plus Ref AS03-RS1-N6
Adam's Hand Plus Ref AH03-RS1-N8-01
Adam's Skin Plus Ref AS03-LS1-N8
Adam's Hand Plus Ref AH03-LS1-B1-01
Adam's Hand Plus Ref AH03-RS1-N1-01
Adam's Hand Plus Ref AH03-LS1-I0-01
Adam's Skin Plus Ref AS03-LS1-B1
Adam's Skin Plus Ref AS03-LS1-N4
Adam's Skin Plus Ref AS03-RS1-N3
Adam's Hand Plus Ref AH03-RS1-W1-01-D
Adam's Skin Plus Ref AS03-LS1-N9
Adam's Hand Plus Ref AH03-RS1-N5-01
Adam's Skin Plus Ref AS03-RS1-N5
Adam's Hand Plus Ref AH03-RS1-B1-01-D
Showing 1-50 of 358
What BionIT Labs S.r.l. makes
BionIT Labs S.r.l. manufactures analog amplifiers, wave electrodes, and prosthetic components including Adam’s Hand and Adam’s Skin, which are designed for neurological and rehabilitative applications.
These devices are classified as Class I under EU regulations and are registered in the EUDAMED database. The company is based in Italy.
Frequently asked questions
What types of medical devices does BionIT Labs S.r.l. manufacture?
BionIT Labs S.r.l. specializes in devices for neurological and rehabilitative applications, including analog amplifiers, wave electrodes, and prosthetic components like Adam’s Hand and Adam’s Skin. These products are designed to support functional recovery or assistive mobility for patients.
Where is BionIT Labs S.r.l. based?
BionIT Labs S.r.l. is headquartered in Italy. The company’s location in Italy aligns with EU regulatory frameworks, which govern the classification and registration of its devices.
Which regulatory registries list BionIT Labs S.r.l.’s devices?
BionIT Labs S.r.l.’s devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This ensures transparency and compliance with EU requirements for Class I devices.
How are BionIT Labs S.r.l.’s devices classified under EU regulations?
All of BionIT Labs S.r.l.’s listed devices fall under Class I classification in the EU. This classification is typically assigned to low-risk devices, such as certain prosthetics, electrodes, and amplifiers, which pose minimal risk to patients when used as intended.
Information
- Country
- Italy
- Address
- 1, Via Cracovia, Soleto, Italy
- Website
- www.bionitlabs.com
- [email protected]
- Phone
- +390836307525
- PRRC contact
- Giacomo Cornara
- EUDAMED SRN
- IT-MF-000007793
- FDA FEI number
- 3018070844