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Cardiac Troponin I/Creatine Kinase-MB/Myoglobin Test Kit (QDs-FICA)

by Chongqing Juce Life Health Technology Co., Ltd.

Ref CA0901Model Specification 1: Cardiac Troponin I / Creatine Kinase-MB / Myoglobin Specification 2: Cardiac Troponin I / Myoglobin Each specification is available in the following pack sizes: 1 test/box, 5 tests/box, 10 tests/box, 50 tests/box, and 100 tests/box.

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, self-declared

Class I: no certifier involved

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-06977981880157 Basic UDI-DI 06977981880157UDI-DIDate21 May 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
Specification 1: Cardiac Troponin I / Creatine Kinase-MB / Myoglobin Specification 2: Cardiac Troponin I / Myoglobin Each specification is available in the following pack sizes: 1 test/box, 5 tests/box, 10 tests/box, 50 tests/box, and 100 tests/box., CA0901
Primary DI / UDI-DI
06977981880157
Basic UDI-DI
B-06977981880157
EMDN Code
W0102160706 Multiple cardiac markers - rt & poc
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000053774
Authorised representative
Share info GmbH DE-AR-000005132

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No