Identity
- Trade Name
- Healthsky EUDAMED
- Device Name
- Slide Unit EUDAMED
- Model / Reference
- FCS-4A FCS-4B EUDAMEDFCS-4B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211624513 EUDAMED
- Basic UDI-DI
- 697721162HSSUPS EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - 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
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
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 (1)
- EUDAMED 38272a58-add7-4fc0-a542-2f965c9ca964 61 fields · synced Jun 19, 2026