Identity
- Trade Name
- KEYU Dry Chemistry Urine Analyzer EUDAMED
- Device Name
- Dry Chemistry Urine Analyzer EUDAMED
- Model / Reference
- KU-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360026 EUDAMED
- Basic UDI-DI
- 697473536KUA03P8 EUDAMED
- EMDN Code
- W020101020101 URINE STRIP READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
KEYU Dry Chemistry Urine Analyzer by Zhuhai Keyu Biological Engineering 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 | 697473536KUA03P8 | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 865ed0f1-be8b-47d3-8ed4-2eb0febfe678 61 fields · synced Jun 19, 2026