Spengler NEO100 (Neotens Nomad)
Device Name:
Neotens Nomad
Device Model:
NEO100
Manufacturer:
Spengler S.a.s., 190 rue Paul Langevin, ZAC La Robole, 13856 Aix-en-Provence, FRANCE.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Spengler NEO100 (Neotens Nomad) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Spengler NEO100 (Neotens Nomad), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Stride BP | Self-measurement for adults | Equivalence to the Sejoy Joytech DBP-8278B claim without published evidence |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Sejoy Joytech DBP-8278B
Zhou Q. Validation of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the ISO 81060-2:2018/AMD 1:2020 protocol. Blood Press Monit. 2025 Feb 1;30(1):36-39. Epub: 2024 Jul 16. doi: 10.1097/MBP.0000000000000717. PMID: 39008688.
81060-2:2018/Amd 1:2020 - Pass General population