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Healthsky
EUDAMEDClass A (EU MDR)
Ref FEA01-2AModel FGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3A
Identity
- Trade Name
- Healthsky EUDAMED
- Device Name
- Liquid-Based Cytology Processing Kit EUDAMED
- Model / Reference
- FGA01-1A FSA01-2A FUA01-2A FEA01-2A FNA01-3A EUDAMEDFEA01-2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211621031 EUDAMED
- Basic UDI-DI
- 697721162HSLBCPKX3 EUDAMED
- EMDN Code
- W01019099 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
Yes
EUDAMED
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
Category: Nucleic acid extraction/isolation kit IVD
Healthsky by Hangzhou HealthSky Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697721162HSLBCPKX3 | 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 (1)
- EUDAMED 1521691b-0a8a-49d8-a088-205ca5af2956 61 fields · synced Jun 18, 2026