Skip to content

Healthsky

by Hangzhou HealthSky Biotechnology Co., Ltd. 21 variants

Ref FPA01-ATModel FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697721162HSPSKP9 Basic UDI-DI 06977211622007UDI-DIDate23 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Papanicolaou Stain Kit
Model / Reference
FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT, FPA01-AT
Primary DI / UDI-DI
06977211622007
Basic UDI-DI
697721162HSPSKP9
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000040002
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou HealthSky Biotechnology Co., Ltd.

See all devices from Hangzhou HealthSky Biotechnology Co., Ltd. →

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