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Reagents for Urine Analyzer
EUDAMEDClass A (EU MDR)
Ref URS-405Ref URS-402Ref URS-409Ref URS-406Ref URS-404Ref URS-408
Identity
- Device Name
- Reagents for Urine Analyzer EUDAMED
- Model / Reference
- URS-405 EUDAMEDURS-402 EUDAMEDURS-409 EUDAMEDURS-406 EUDAMEDURS-404 EUDAMEDURS-408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974410140103 EUDAMED06974410140073 EUDAMED06974410140134 EUDAMED06974410140141 EUDAMED06974410140097 EUDAMED06974410140127 EUDAMED
- Basic UDI-DI
- 697441014RUA0004HR EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMEDItaly 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 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 | 697441014RUA0004HR | 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 (6)
- EUDAMED 130f34d5-f0c7-4f14-ac79-5ce7ecfd6f06 61 fields · synced Jul 24, 2026
- EUDAMED 37c33523-60a0-4ce1-8fe8-a5df93f8046d 61 fields · synced May 16, 2026
- EUDAMED 2ddf2162-04c5-4ca7-80fa-dac5f0d34060 61 fields · synced May 17, 2026
- EUDAMED 7ffb83ce-bb68-4130-b784-f217abbc199b 61 fields · synced May 18, 2026
- EUDAMED 6b8437c7-b1b2-4c44-ab58-fa3d2ac1d309 61 fields · synced May 18, 2026
- EUDAMED dfe06a9e-602b-4f49-9862-1c522570295f 61 fields · synced May 18, 2026