Identity
- Trade Name
- Yumizen G1550h EUDAMED
- Device Name
- Yumizen G1500 EUDAMED
- Model / Reference
- 1300036330 EUDAMED1300115427 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009505 EUDAMED
- Basic UDI-DI
- 361023ymz_g15x0QK EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Yumizen G1550h by Horiba Abx Sas — Class A — 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_g15x0QK | Class A | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (1)
- EUDAMED 7cf68e36-3423-4bcb-8ede-879c3ff4e9b7 61 fields · synced Jul 18, 2026