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Automatic Hematology Analyzer

by Genegeo Diagnostics (Jiangsu) Co., Ltd. EUDAMED

Active European Union

Ref 200101000013, 200103000014, 200101000011, 200103000013, 200108000002, 200105000003, 200105000005, 200106000015, 200108000001, 200106000003, 200103000012, 200105000001, 200103000011Model DX-80S, DX-100W, DX-80, DX-100P, DX-60i, DX-120C, DX-120CR, DX-8P, DX-60, DX-8P2, DX-100R, DX-120, DX-100

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697615409DX-80SHN Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
DX-80S, 200101000013, DX-100W, 200103000014, DX-80, 200101000011, DX-100P, 200103000013, DX-60i, 200108000002, DX-120C, 200105000003, DX-120CR, 200105000005, DX-8P, 200106000015, DX-60, 200108000001, DX-8P2, 200106000003, DX-100R, 200103000012, DX-120, 200105000001, DX-100, 200103000011
Primary DI / UDI-DI
06976154090300, 06976154090362, 06976154090041, 06976154090355, 06976154090553, 06976154090201, 06976154090225, 06976154091505, 06976154090546, 06976154090256, 06976154090348, 06976154090188, 06976154090331
Basic UDI-DI
697615409DX-80SHN, 697615409DX-100WG7, 697615409DX-80G2, 697615409DX-100PFR, 697615409DX-60iJE, B-06976154090201, B-06976154090225, B-06976154091505, 697615409DX-60FU, B-06976154090256, 697615409DX-100RFV, B-06976154090188, 697615409DX-100EF
EMDN Code
W0202010101, W0202010102
Device Class
Class A
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000052709
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • 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