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Yumizen H500 OT
EUDAMEDClass B (EU MDR)
Ref 1300092658, 1300092659, 1300092720, 1300092721
Identity
- Trade Name
- Yumizen H500 OT EUDAMED
- Device Name
- Yumizen H500 OT EUDAMED
- Model / Reference
- 1300092658, 1300092659, 1300092720, 1300092721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009345 EUDAMED
- Basic UDI-DI
- 361023ymz_h500_otMW EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yumizen H500 OT by Horiba Abx Sas — Class B — 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 | 361023ymz_h500_otMW | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED 9da94162-2a49-486a-9f0d-93442ce8a232 61 fields · synced Jul 16, 2026
- EUDAMED 9da94162-2a49-486a-9f0d-93442ce8a232-1 61 fields · synced Jun 10, 2026