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Reagents for Urine Sediment Analyzer
EUDAMEDClass A (EU MDR)
Ref URS-300Ref URS-100
Identity
- Trade Name
- Reagents for Urine Sediment Analyzer EUDAMED
- Device Name
- Reagents for Urine Sediment Analyzer EUDAMED
- Model / Reference
- URS-300 EUDAMEDURS-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974410140042 EUDAMED06974410140028 EUDAMED
- Basic UDI-DI
- 697441014RUS0011PU EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Reagents for Urine Sediment Analyzer by Bioway Biological Technology 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 | 697441014RUS0011PU | Class A | Active |
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Manufacturer
- Manufacturer
- Bioway Biological Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026464
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 47cb2848-0278-446f-b282-f71613138eb5 61 fields · synced Jul 26, 2026
- EUDAMED 28d064fe-7c52-4eb9-b8a2-c3da7a7da5c5 61 fields · synced May 17, 2026