E-Swin
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000011807
Part of E-Swin SAS
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.
- Devices
- 8
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 5
- FDA GUDID 2
- FDA 510(k) 1
- Device classes
- EU Class IIa 5
- FDA Class I 2
- FDA Class II 1
- Top EMDN categories
- Sites and related companies
- Identifiers
- EUDAMED SRN FR-MF-000011807
- DUNS 267700713
At a glance
EU certificates
1 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What E-Swin makes
E-Swin manufactures corneal topography systems and analysers designed for ocular surface assessment, including devices like the TearCheck T for tear film evaluation and the E>EyeC for corneal mapping. These tools are used in clinical settings to measure corneal curvature, dry eye metrics, and other anterior segment parameters.
The company’s portfolio includes devices authorised under FDA pathways, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) and UDI registries, reflecting their regulatory compliance in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
E>075 Ref D006AF001A12A
Regimes: CE MDD Registry: EUDAMEDE>EyeC Ref K200616
Regimes: 510(k) Registry: 510(k)E>One Clinic Evolution Ref D005AF001A02A
Regimes: CE MDD Registry: EUDAMEDtearcheck Ref D036AF001A08A
Regimes: CE MDR Registry: EUDAMEDE-One Clinic RC Ref D002AF004Bxxx
Regimes: CE MDD Registry: EUDAMEDWe>o Ref D029AF001B13A
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000011807
- DUNS number
- 267700713
- EU VAT number
- FR39501515423
- EUDAMED status
- Active
- EUDAMED registered name
- E-SWIN SAS
- EUDAMED abbreviated name
- E-SWIN
- Registered address
- Rue des côtes d'Orval, 78550, Houdan, France
- Website
- e-swin.com/fr/accueil
- contact@e-swin.com
- Phone
- +33 1 30 46 37 61
- PRRC contact
- David MACE
EUDAMED certificates
2 certificates1 valid, 0 expired, 1 withdrawn or suspendedMDR 2next expiry 23 May 2028
Intertek Medical Notified Body AB 2862 1 certificate
- 28620240995 Active
Quality management system EU MDR
- Issued
- 24 Mar 2026
- Expires
- 23 May 2028
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1024982-1 Cancelled
Quality management system EU MDR
- Issued
- 2 Mar 2025
- Expires
- 23 May 2028
- Reason
- Other
Frequently asked questions
How many devices does E-Swin have in the registry?
The registry currently lists 8 devices for E-Swin. Devices recorded under merged duplicate company entries are counted once.
Which registries list E-Swin's devices?
Among its 8 most recently registered devices, E-Swin has devices listed in EUDAMED (5 devices), FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do E-Swin's devices fall under?
Among its 8 most recently registered devices, the classes recorded for E-Swin's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for E-Swin?
EUDAMED lists 2 certificates for E-Swin (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Mar 2026.
What are the newest devices from E-Swin in the registry?
The most recently registered devices listed for E-Swin include TearCheck T N040US000A08A, TearCheck T V040US000A08A, E>075 and E>EyeC.