Identity
- Trade Name
- Atellica HEMA 530 EUDAMED
- Device Name
- Atellica HEMA 530 EUDAMED
- Model / Reference
- 1300128174 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009536 EUDAMED
- Basic UDI-DI
- 361023at_530GF 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
Atellica HEMA 530 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 | 361023at_530GF | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (1)
- EUDAMED 1aa3692e-51e9-4f40-8e50-fc190b849520 61 fields · synced Jun 19, 2026