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KEYU ParaSpin™ Intestinal Parasite Concentrator
EUDAMEDClass A (EU MDR)
Ref KU-F05-IVRef KU-F05-I
Identity
- Trade Name
- KEYU ParaSpin™ Intestinal Parasite Concentrator EUDAMED
- Device Name
- ParaSpin™ Intestinal Parasite Concentrator EUDAMED
- Model / Reference
- KU-F05-IV EUDAMEDKU-F05-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361825 EUDAMED06974735361801 EUDAMED06974735362129 EUDAMED
- Basic UDI-DI
- 697473536KUC23PQ EUDAMED697473536KUC21PL 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 ParaSpin™ Intestinal Parasite Concentrator 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 | 697473536KUC23PQ | 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 (3)
- EUDAMED c9689149-c23c-4aa9-8caf-c53f93dba884 61 fields · synced Oct 6, 2026
- EUDAMED 9bc9c3fb-cdfa-40ba-b6a8-19813b0185ec 61 fields · synced May 18, 2026
- EUDAMED 3500cb7c-5bd7-4e8d-b1bc-19c008ce8803 61 fields · synced May 19, 2026