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Erka. Erkaphon

by ERKA Kallmeyer Medizintechnik GmbH & Co. Kommanditgesellschaft 5 variants

Ref 543.00060.7590, 543.00080.7590, 543.00000.7590, 543.00010.7590, 543.00025.7590, 543.00055.7590, 544.00005.7590, 544.00035.7590, 544.70010.7590, 544.00060.7590Model Erkaphon, Erkaphon Alu

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 Number42502961543LU Basic UDI-DI Date29 Sep 2025RegisteredStatusActive

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  • Withdrawn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

Trade Name
Erka. Erkaphon
Erka. Erkaphon Alu
Erka. Erkaphon Alu Blackline
Device Name
Erkaphon
Erkaphon Alu
Model / Reference
Erkaphon, 543.00060.7590, 543.00080.7590, 543.00000.7590, 543.00010.7590, 543.00025.7590, 543.00055.7590, Erkaphon Alu, 544.00005.7590, 544.00035.7590, 544.70010.7590, 544.00060.7590
Primary DI / UDI-DI
04250296129541, 04250296158749, 04250296129435, 04250296129466, 04250296158718, 04250296156479, 04250296156189, 04250296157124, 04250296165891, 04250296129718
Basic UDI-DI
42502961543LU, 42502961544LW
EMDN Code
C9005 Phonendoscopes and stethoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000009663

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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