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Serum Amyloid A Protein Reagent (Immunonephelometric Method)

by Shenzhen Dymind Biotechnology Co., Ltd.

Ref XQ-0010-09Model Model:SAA II Specification:1×13 mL、1×25 mL、1×45 mL、1×75 mL、1×90 mL、2×13 mL、2×25 mL、2×45 mL、2×75 mL, SAA II 2×75 mL

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 linked in EUDAMED

A group certificate may exist

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/IVDR Number697049309W01023007042CP Basic UDI-DI 06970493099024UDI-DIDate2 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Model:SAA II Specification:1×13 mL、1×25 mL、1×45 mL、1×75 mL、1×90 mL、2×13 mL、2×25 mL、2×45 mL、2×75 mL, XQ-0010-09, SAA II 2×75 mL
Primary DI / UDI-DI
06970493099024
Basic UDI-DI
697049309W01023007042CP, B-06970493099024
Direct Marketing DI
06970493099024
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - other
Device Class
Class C
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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