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Chlamydia pneumoniae IgM

by Gold Standard Diagnostics Frankfurt GmbH

Ref RE57051

Active European Union

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-+ENTIRE570510C Basic UDI-DI +ENTIRE570510CUDI-DIDate8 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Chlamydia pneumoniae IgM
Model / Reference
RE57051
Primary DI / UDI-DI
+ENTIRE570510C
Basic UDI-DI
B-+ENTIRE570510C
EMDN Code
W0105010116 Chlamydia pneumoniae antibody igm
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025020

Other devices from Gold Standard Diagnostics Frankfurt GmbH

See all devices from Gold Standard Diagnostics Frankfurt GmbH →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No