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Anti-Streptolysin O (ASO) Calibrator

by Maccura Biotechnology Co., Ltd.

Ref ECH0182301, ECH0105314, ECH0504314, ECH0506314, ECH0502314, ECH0183301, ECH0181301, ECH0505314

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ECH01823017K Basic UDI-DI Date22 May 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Anti-Streptolysin O (ASO) Calibrator
Anti-Streptolysin O (ASO)
Model / Reference
ECH0182301, ECH0105314, ECH0504314, ECH0506314, ECH0502314, ECH0183301, ECH0181301, ECH0505314
Primary DI / UDI-DI
D-ECH01823017K, D-ECH01053145R, D-ECH050431476, D-ECH05063147L, D-ECH05023146Q, D-ECH01833017S, D-ECH01813017C, D-ECH05053147D
Basic UDI-DI
B-ECH01823017K, B-ECH01053145R, B-ECH050431476, B-ECH05063147L, B-ECH05023146Q, B-ECH01833017S, B-ECH01813017C, B-ECH05053147D
EMDN Code
W0102152299, W01021104
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Human Tissues YesEUDAMEDNoEUDAMED
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing

Other properties (6)

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