Skip to content

Pylon BNP

by ET Healthcare (Suzhou) Co., Ltd. China EUDAMED

Ref 10-2047 40 tests/kitModel 40 tests/kit 100 tests/kit 200 tests/kit

EMDN W01021301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502BNPV3 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
40 tests/kit 100 tests/kit 200 tests/kit, 10-2047 40 tests/kit
Primary DI / UDI-DI
06976485022780
Basic UDI-DI
697648502BNPV3
Direct Marketing DI
06976485022780
EMDN Code
W01021301 Bnp / probnp (including other natriuric peptides)
Device Class
Class C

Manufacturer details

EUDAMED SRN
CN-MF-000039448
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from ET Healthcare (Suzhou) Co., Ltd.

See all devices from ET Healthcare (Suzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 3e13ed66-24d8-42c5-bc44-b5c702f95470 61 fields · synced 22 Oct 2026