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2107202-001

by Lumitex Medical Devices, Inc.

Ref 2107202-001Model Disposables Pad Covers and Pad Nests Product Family

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081243202MD078QM Basic UDI-DI 10812432022539UDI-DIDate1 Feb 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Disposables Pad Covers and Pad Nests Product Family, 2107202-001
Primary DI / UDI-DI
10812432022539
Basic UDI-DI
081243202MD078QM
Unit of Use DI
00812432022532
EMDN Code
Z12080499 Neonatology instruments - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000030520
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Lumitex Medical Devices, Inc.

See all devices from Lumitex Medical Devices, Inc. →

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