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Enlight 2100

by Timpel S.A.

Ref TPL-E2100-1

Enlight 2100 (TPL-E2100-1) is a medical device (EU MDR Class IIa; EMDN category bioimaging viewing monitors) made by Timpel S/A, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 7898959841ENLIGHTR8), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7898959841ENLIGHTR8 Basic UDI-DI 07898966433559UDI-DIDate4 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Electrical Impedance Tomography
Model / reference
TPL-E2100-1
Primary DI / UDI-DI
07898966433559
Basic UDI-DI
7898959841ENLIGHTR8
Direct marketing DI
07898966433559
EMDN code
Z11900802 Bioimaging viewing monitors
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
BR-MF-000015742
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under BIOIMAGING VIEWING MONITORS.

Other devices from Timpel S/A

See all devices from Timpel S/A →

Properties

  • Measuring function
Other properties (13, all answered No)