Identity
- Trade Name
- UD-10 EUDAMEDFully Automated Urine Particle Digital Imaging Device UD-10 FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- Fully Automated Urine Particle Digital Imaging Device EUDAMEDFully Automated Urine Particle Digital Imaging Device UD-10 FDA UDI
- Model / Reference
- CJ445012 EUDAMEDFDA UDI
- Description
- Fully Automated Urine Particle Digital Imaging Device UD-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562444779 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562UD-1037 EUDAMED
- FDA Product Code
- JOY FDA UDI
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ud-10 by Sysmex Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987562UD-1037 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 89d1217c-decf-49c4-81ba-881dd787f9f7 61 fields · synced Jul 22, 2026
- FDA UDI 0adcde7f-fb56-4223-b136-542b9f1ba1e2 34 fields · synced May 30, 2026