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Hcu01
EUDAMEDClass A (EU MDR)
Ref HCU01Model HCU01, HCU02
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Model / Reference
- HCU01, HCU02 EUDAMEDHCU01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535232 EUDAMED
- Basic UDI-DI
- 693482255700J5 EUDAMED
- Direct Marketing DI
- 06934822535232 EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Hcu01 by Jiangsu Konsung Bio-Medical Science And Technology 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 | 693482255700J5 | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 20c4403a-832e-4f70-9b39-813bbef75c66 61 fields · synced Oct 6, 2026