Identity
- Trade Name
- Yumizen G CAL EUDAMED
- Device Name
- Yumizen G CAL EUDAMED
- Model / Reference
- 1300036416 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230008423 EUDAMED
- Basic UDI-DI
- 361023ymz_g_cal94 EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Yumizen G CAL by Horiba Abx Sas — Class C — 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_g_cal94 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (1)
- EUDAMED 0c5f626e-ada2-4e6b-bfa5-00f3abc920d2 61 fields · synced Jul 19, 2026