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Angiotensin Converting Enzyme (ACE) Kit (Enzymatic Colorimetric Assay Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref 105-006180-00Model 105-006179-00、105-002248-00、105-002249-00、105-006180-00、105-004509-00、105-004510-00、105-002313-00、105-002314-00

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004JACE********SA Basic UDI-DIDate19 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
Angiotensin Converting Enzyme Kit (Enzymatic Colorimetric Assay Method)、ACE Calibrator、 ACE Control
Model / Reference
105-006179-00、105-002248-00、105-002249-00、105-006180-00、105-004509-00、105-004510-00、105-002313-00、105-002314-00, 105-006180-00
Primary DI / UDI-DI
06944904053769
Basic UDI-DI
69449040004JACE********SA
EMDN Code
W01010109 Angiotensin converting enzyme (cc)
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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