Identity
- Trade Name
- Yumizen P8000 EUDAMEDFDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- Yumizen P8000 EUDAMED1 connexion FDA UDI
- Model / Reference
- 1300033327 EUDAMEDFDA UDI
- Description
- 1 connexion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230008966 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023ymz_p8000N8 EUDAMED
- Direct Marketing DI
- 03610230008966 EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W0202010182 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Yumizen P8000 by Horiba Abx Sas — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 361023ymz_p8000N8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED 6e990dc7-ee70-424d-aa82-1c34db1f4d00 61 fields · synced Jun 19, 2026
- FDA UDI 8ce7f34c-03af-4023-90a2-df1b0986ac52 33 fields · synced May 27, 2026