Healthsky

by Hangzhou HealthSky Biotechnology Co., Ltd. 21 variants

Ref FGA01-1AModel FGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3A FGA01-1AP

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

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697721162HSLBCPKX3 Basic UDI-DI	Date23 Apr 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Liquid-Based Cytology Processing Kit
Model / Reference: FGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3A FGA01-1AP, FGA01-1A

Primary DI / UDI-DI: 06977211621000, 06977211620270, 06977211620324
Basic UDI-DI: 697721162HSLBCPKX3
Unit of Use DI: 16977211620321
EMDN Code: W01019099 Clinical chemistry reagents - other

Device Class: Class A
EU market of registration: Italy
Austria

Manufacturer details

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

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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