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TearStim

by E-Swin SAS

Ref D037AF001B08A

TearStim (D037AF001B08A) is a medical device (EU MDR Class IIb; EMDN category generic photostimulators) made by E-Swin SAS, registered in EUDAMED on 8 Jun 2023 (Basic UDI-DI 3662824D037AF001B08AVX) with CE/MDR certificate 28620240995 valid until 23 May 2028, active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

23 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number28620240995 Date24 Mar 2026IssuedStatusActive expires 23 May 2028

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

3 dated events

  1. Registered EUDAMED 3662824D037AF001B08AVX
  2. Certificate issued EUDAMED 28620240995
  3. Certificate expires EUDAMED 28620240995

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
D037AF001B08A
Primary DI / UDI-DI
03662824001440
Basic UDI-DI
3662824D037AF001B08AVX
EMDN code
Z129005 Generic photostimulators
Device class
Class IIb
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011807

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS.

Other devices from E-Swin SAS

  • E-Eye

    Class IIb

Properties

Other properties (14, all answered No)