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Healthsky
EUDAMEDClass A (EU MDR)
Ref FCS-4AModel FCS-4A FCS-4BRef FPA01-ETModel FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MTRef FDA01-MTRef FUA01-2AModel FGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3ARef FGA01-1ARef FPA01-ATRef FCA02-NTModel FCA01-JA FCA01-JB FCA02-NT FCA03-JT FCA03-PTRef FPA02-ETRef FCA03-PTRef FCA03-JTRef FPA01-BTRef FPA02-GT
Identity
- Trade Name
- Healthsky EUDAMED
- Device Name
- Slide Unit EUDAMEDPapanicolaou Stain Kit EUDAMEDDiluent EUDAMEDLiquid-Based Cytology Processing Kit EUDAMEDCell Preservation Vial EUDAMED
- Model / Reference
- FCS-4A FCS-4B EUDAMEDFCS-4A EUDAMEDFPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT EUDAMEDFPA01-ET EUDAMEDFDA01-MT EUDAMEDFGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3A EUDAMEDFUA01-2A EUDAMEDFGA01-1A EUDAMEDFPA01-AT EUDAMEDFCA01-JA FCA01-JB FCA02-NT FCA03-JT FCA03-PT EUDAMEDFCA02-NT EUDAMEDFPA02-ET EUDAMEDFCA03-PT EUDAMEDFCA03-JT EUDAMEDFPA01-BT EUDAMEDFPA02-GT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211624520 EUDAMED06977211622038 EUDAMED06977211626012 EUDAMED06977211621024 EUDAMED06977211621000 EUDAMED06977211622007 EUDAMED06977211624025 EUDAMED06977211622014 EUDAMED06977211624049 EUDAMED06977211624032 EUDAMED06977211622052 EUDAMED06977211622045 EUDAMED
- Basic UDI-DI
- 697721162HSSUPS EUDAMED697721162HSPSKP9 EUDAMED697721162HSDIMM EUDAMED697721162HSLBCPKX3 EUDAMED697721162HSCPVMM EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMEDW01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMEDW01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMEDW01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Healthsky by Hangzhou HealthSky Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697721162HSSUPS | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou HealthSky Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040002
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (12)
- EUDAMED 167da706-058e-46c9-8501-81a31ac3fd7f 61 fields · synced Aug 4, 2026
- EUDAMED 59dfe6d0-9342-4dcc-a430-84e3cb5bdff2 61 fields · synced May 16, 2026
- EUDAMED c9e30874-5078-4e07-a16c-4f2930ae1ffe 61 fields · synced May 16, 2026
- EUDAMED 01add0ca-4049-4eba-a845-8c879d377ffb 61 fields · synced May 17, 2026
- EUDAMED e229d331-97cf-4c8f-9fae-fa8417fe1591 61 fields · synced May 17, 2026
- EUDAMED 35efee10-2333-4bac-a921-4b0284e017ad 61 fields · synced May 18, 2026
- EUDAMED 940f24aa-f1c4-4ccb-8035-e45905291b3d 61 fields · synced May 18, 2026
- EUDAMED f6ee50cb-b01f-468b-9cda-31147141abaa 61 fields · synced May 18, 2026
- EUDAMED 74cfb599-6ba5-4d1f-9b81-24c007501825 61 fields · synced May 18, 2026
- EUDAMED 6803e91e-3f0d-4109-845f-6308a3434f30 61 fields · synced May 18, 2026
- EUDAMED 6e4977c1-9bd7-4120-9ef4-0e44ad9ebb30 61 fields · synced May 18, 2026
- EUDAMED c036d288-a25d-424a-85db-3f33d6d10fca 61 fields · synced May 19, 2026