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Rheumatoid Factor (RF) Serum Test

by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. China EUDAMED

Ref R15-110 EMDN W0102160699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941571815003 Basic UDI-DIDate16 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Rheumatoid Factor (RF) Serum Test
Model / Reference
R15-110
Primary DI / UDI-DI
06941571815003
Basic UDI-DI
B-06941571815003
EMDN Code
W0102160699 Rheumatoid / inflammatory disease rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000020607
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

See all devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d20fb0cd-04a5-4a85-acac-7e813bbf86d4 61 fields · synced 24 Oct 2026