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Yumizen H2500 (Yumizen SPS connectable)
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 1300102148
Identity
- Trade Name
- Yumizen H2500 (Yumizen SPS connectable) EUDAMEDYumizen H2500 FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- Yumizen H2500 EUDAMED
- Model / Reference
- 1300102148 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230009451 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 (Yumizen SPS connectable) by Horiba Abx Sas — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232946 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 361023ymz_h2500JX | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (3)
- EUDAMED 2965953c-fb80-47ea-bfcb-b9b014a2c9f0 61 fields · synced Jul 11, 2026
- FDA UDI dc5df249-0703-4d72-b7f5-726e333c87d7 33 fields · synced May 29, 2026
- FDA 510(k) K232946 1 fields · synced May 18, 2026