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Electrolyte Analyzer

by Shenzhen Xilaiheng Medical Electronics Co., Ltd. 2 variants

Ref /Model EA2000, EA2100, EA2200, EA2300

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697520038EA2000ZF Basic UDI-DI 06975200380938UDI-DIDate18 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Electrolyte Analyzer
Model / Reference
EA2000, EA2100, EA2200, EA2300, /
Primary DI / UDI-DI
06975200380938
Basic UDI-DI
697520038EA2000ZF
Direct Marketing DI
06975200380938
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000047090
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Xilaiheng Medical Electronics Co., Ltd.

Properties

  • Surgical Instrument

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No