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KEYU Sample Collection Cup
EUDAMEDClass A (EU MDR)
Ref KU-CUP-004Ref KU-CUP-002Ref KU-CUP-003
Identity
- Trade Name
- KEYU Sample Collection Cup EUDAMED
- Device Name
- Sample Collection Cup EUDAMED
- Model / Reference
- KU-CUP-004 EUDAMEDKU-CUP-002 EUDAMEDKU-CUP-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735360736 EUDAMED06974735362112 EUDAMED06974735360675 EUDAMED06974735360729 EUDAMED
- Basic UDI-DI
- 697473536KUC07PS EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
KEYU Sample Collection Cup 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 | 697473536KUC07PS | 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 (4)
- EUDAMED 0e586b19-e2c2-49e2-9051-5cd3c7026026 61 fields · synced Aug 2, 2026
- EUDAMED 2e722dad-303c-44c6-82c4-a56172907c92 61 fields · synced May 16, 2026
- EUDAMED 59be8854-cbc4-4e49-836d-d7719558bc92 61 fields · synced May 18, 2026
- EUDAMED 176f4bfa-027d-4ba4-84d5-e837f49011cb 61 fields · synced May 19, 2026