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elisa 800 R-VIT

by Löwenstein Medical Innovation GmbH & Co. KG

Ref AG-370831Model elisa 600/800

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Overview

The Elisa 800 R-VIT is a sterile medical device designed for the in vitro diagnosis of endocrine disorders. This Class IIb medical instrument features a highly sensitive and specific assay, making it an ideal tool for accurate patient diagnosis.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426019209elisa600/800YP Basic UDI-DI 04260192091408UDI-DIDate3 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
elisa 600/800, AG-370831
Primary DI / UDI-DI
04260192091408
Basic UDI-DI
426019209elisa600/800YP
Direct Marketing DI
04260192091408
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000016838

Other devices from Löwenstein Medical Innovation GmbH & Co. KG

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Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No