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Healthsky
EUDAMEDClass A (EU MDR)
Ref FCA01-JBModel FCA01-JA FCA01-JB FCA02-NT FCA03-JT FCA03-PT
Identity
- Trade Name
- Healthsky EUDAMED
- Device Name
- Cell Preservation Vial EUDAMED
- Model / Reference
- FCA01-JA FCA01-JB FCA02-NT FCA03-JT FCA03-PT EUDAMEDFCA01-JB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977211624018 EUDAMED
- Basic UDI-DI
- 697721162HSCPVMM EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY 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
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 | 697721162HSCPVMM | 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 098f5301-e69d-474b-b2a2-e1d06dfdd275 61 fields · synced Oct 5, 2026