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Pylon Diluent 66

by ET Healthcare (Suzhou) Co., Ltd. 2 variants

Ref 22-0055Model 2 bottles (30 mL/bottle)/ kit

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697648502D66RN Basic UDI-DI 06976485022568UDI-DIDate13 May 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
2 bottles (30 mL/bottle)/ kit, 22-0055
Primary DI / UDI-DI
06976485022568
Basic UDI-DI
697648502D66RN
Direct Marketing DI
06976485022568
EMDN Code
W0102010114 Buffers (unassignable), supplem. reagents, etc (ig's)
Device Class
Class A

Manufacturer details

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

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No