Identity
- Trade Name
- Yumizen H2500 EUDAMEDFDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- Yumizen H2500 EUDAMED
- Model / Reference
- 1300102147 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230009444 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023ymz_h2500JX EUDAMED
- 510(k) Number
- K232946 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr) EUDAMED
- GMDN Term
- Haematological cell analyser IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- France 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
No
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
No
FDA UDI
Yumizen H2500 by Horiba Abx Sas — Class B — 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 | 361023ymz_h2500JX | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED 7d756062-78cd-4c65-9e71-bbe6d790c150 61 fields · synced Jul 9, 2026
- FDA UDI 2f8b6604-b5fb-40bf-8901-7ed554325a48 33 fields · synced May 30, 2026