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KEYU Urine Sample Collection Tube
EUDAMEDClass A (EU MDR)
Ref TUBE-U-12-2Ref TUBE-U-12-1
Identity
- Trade Name
- KEYU Urine Sample Collection Tube EUDAMED
- Device Name
- Urine Sample Collection Tube EUDAMED
- Model / Reference
- TUBE-U-12-2 EUDAMEDTUBE-U-12-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974735361009 EUDAMED06974735360989 EUDAMED06974735360972 EUDAMED
- Basic UDI-DI
- 697473536KUC08PU EUDAMED
- EMDN Code
- W05010202 URINE COLLECTION, TUBES 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
KEYU Urine Sample Collection Tube 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 | 697473536KUC08PU | 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 (3)
- EUDAMED 547756d4-b5a2-4384-9290-8575c2bab80d 61 fields · synced Sep 18, 2026
- EUDAMED d3eacbd1-e988-450a-a7b3-86dd5433f017 61 fields · synced May 17, 2026
- EUDAMED e234d535-9073-4174-83a3-97d7c139d7d9 61 fields · synced May 17, 2026