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Yumizen H500E OT
EUDAMEDClass B (EU MDR)
Ref 1300129738, 1300129760, 1300129761, 1300129762
Identity
- Trade Name
- Yumizen H500E OT EUDAMED
- Device Name
- Yumizen H500E OT EUDAMED
- Model / Reference
- 1300129738, 1300129760, 1300129761, 1300129762 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009550 EUDAMED
- Basic UDI-DI
- 361023ymz_h500E_otSZ 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 H500E 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_h500E_otSZ | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED ed3fe54c-e2a0-46f3-ab15-6626069e4908 61 fields · synced Jul 14, 2026
- EUDAMED ed3fe54c-e2a0-46f3-ab15-6626069e4908-1 61 fields · synced Jun 9, 2026