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KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova)
EUDAMEDClass A (EU MDR)
Ref KU-F05-II
Identity
- Trade Name
- KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova) EUDAMED
- Device Name
- ParaFloat™ Intestinal Parasite Concentrator (Ova) EUDAMED
- Model / Reference
- KU-F05-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361818 EUDAMED
- Basic UDI-DI
- 697473536KUC22PN EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova) by Zhuhai Keyu Biological Engineering Co., Ltd — Class A — IVDR — listed in EUDAMED
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 | 697473536KUC22PN | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai Keyu Biological Engineering Co., Ltd
- EUDAMED SRN
- CN-MF-000023195
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a8f5971e-9736-444e-9a82-234c341bc77a 61 fields · synced Jul 17, 2026