# E-Swin

> Medical device manufacturer record on deviCERTS, compiled from public registries. E-Swin is a medical device manufacturer based in France, with 8 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa; FDA Class I and II) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/e-swin>
- Registered in EUDAMED as: E-SWIN SAS (E-SWIN)
- Country: France (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer, Part of a group
- Registrations: EUDAMED
- EUDAMED SRN: FR-MF-000011807
- DUNS: 267700713

## Figures

- Devices: 8
- EU certificates: 2
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 5, FDA GUDID 2, FDA 510(k) 1
- Device classes: EU Class IIa 5, FDA Class I 2, FDA Class II 1
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 4 devices
- EMDN [X05 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body for skin resurfacing, tattoo](https://devicerts.com/categories/emdn/X05): 1 devices

## Sites and related companies

- Part of [E-Swin SAS](https://devicerts.com/manufacturers/e-swin-sas)

## Devices

The first 8 of 8, in the order of the canonical page, which lists them all.

- [TearCheck T N040US000A08A](https://devicerts.com/devices/tearcheck-t-n040us000a08a) · Class I · GUDID · status: Listed
- [TearCheck T V040US000A08A](https://devicerts.com/devices/tearcheck-t-v040us000a08a) · Class I · GUDID · status: Listed
- [E\>075](https://devicerts.com/devices/e-075-d006af001a12a) · ref D006AF001A12A · Class IIa · EUDAMED · status: Active
- [E\>EyeC](https://devicerts.com/devices/e-eyec-onf) · ref K200616 · Class II · 510(k) · status: Active · decision 2020-06-11
- [E\>One Clinic Evolution](https://devicerts.com/devices/e-one-clinic-evolution-d005af001a02a) · ref D005AF001A02A · Class IIa · EUDAMED · status: Active
- [tearcheck](https://devicerts.com/devices/tearcheck-d036af001a08a) · ref D036AF001A08A · Class IIa · EUDAMED · status: Active
- [E-One Clinic RC](https://devicerts.com/devices/e-one-clinic-rc-d002af004bxxx) · ref D002AF004Bxxx · Class IIa · EUDAMED · status: Active
- [We\>o](https://devicerts.com/devices/we-o-d029af001b13a) · ref D029AF001B13A · Class IIa · EUDAMED · status: Active

## EU certificates

- 28620240995 · Quality management system · MDR · notified body Intertek Medical Notified Body AB · issued 2026-03-24 · expires 2028-05-23 · status: issued
- HZ 1024982-1 · Quality management system · MDR · notified body TÜV Rheinland LGA Products GmbH · issued 2025-03-02 · expires 2028-05-23 · status: cancelled

## Source and citation

- Cite as: E-Swin. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/e-swin (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/e-swin.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/e-swin
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.