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Automated Chemistry Analyzer

by Ningbo MedicalSystem Biotechnology Co., Ltd. China EUDAMED

Ref B48010AModel MS-420P,MS-400P,MS-380P,MS-420,MS-400,MS-380,MS-480,MS-450,MS-520,MS-600,MS-680

EMDN W0201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697509661MSC001P5 Basic UDI-DIDate5 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
MS-420P, MS-400P, MS-380P, MS-420, MS-400, MS-380, MS-480, MS-450, MS-520, MS-600, MS-680, B48010A
Primary DI / UDI-DI
06975096611154
Basic UDI-DI
697509661MSC001P5
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014369
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Ningbo MedicalSystem Biotechnology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 02d6a7eb-de68-4609-864a-961a177c7a2f 61 fields · synced 24 Oct 2026