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Serum Amyloid A Protein Reagent (Immunonephelometric Method)

by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref XQ-0010-08Model SAA II 2×45 mL, 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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06970493099017 Basic UDI-DIDate8 Jun 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06970493099017 Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
SAA II 2×45 mL, XQ-0010-08, 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
Primary DI / UDI-DI
06970493099017
Basic UDI-DI
B-06970493099017, 697049309W01023007042CP
Direct Marketing DI
06970493099017
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - other
Device Class
Class IVD General
Class C
Market of Registration
Germany

Manufacturer details

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

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Properties

Show 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