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ENLIGHT Disposable Belt - Size N1

by Timpel S.A.

Ref ACE-00003-0

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7898959841DISPBELTAE Basic UDI-DI 07898959841507UDI-DIDate20 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Neonatal Electrode Belt
Model / Reference
ACE-00003-0
Primary DI / UDI-DI
07898959841507
Basic UDI-DI
7898959841DISPBELTAE
Direct Marketing DI
07898959841507
EMDN Code
V9015 Electrodes and probes cutaneous conductive substances
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

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

Other devices from Timpel S.A.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No