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skyla

by Skyla Corporation Hsinchu Science Park Branch 2 variants

Ref 800-001AModel HB-P02

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471987865800-001AVW Basic UDI-DI 04719878650014UDI-DIDate24 Feb 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
skyla Clinical Chemistry Analyzer
Model / Reference
HB-P02, 800-001A
Primary DI / UDI-DI
04719878650014
Basic UDI-DI
471987865800-001AVW
Direct Marketing DI
04719878650014
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000007751
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Skyla Corporation Hsinchu Science Park Branch

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