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Pss-05B

by Hangzhou HealthSky Biotechnology Co., Ltd.

Ref PSS-05BModel PSS-05A、PSS-80A、PSS-120A、PSS-160A、PSS-320A、PSS-480A PSS-05B、PSS-80B、PSS-120B、PSS-160B、PSS-320B、PSS-480B

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 Number697721162IWSISQH Basic UDI-DI 06977211620089UDI-DIDate7 May 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  • Withdrawn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

Model / Reference
PSS-05A、PSS-80A、PSS-120A、PSS-160A、PSS-320A、PSS-480A PSS-05B、PSS-80B、PSS-120B、PSS-160B、PSS-320B、PSS-480B, PSS-05B
Primary DI / UDI-DI
06977211620089
Basic UDI-DI
697721162IWSISQH
EMDN Code
W0202050301 Electron microscopes
Device Class
Class A
EU market of registration
Austria

Manufacturer details

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

Other devices from Hangzhou HealthSky Biotechnology Co., Ltd.

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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