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Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref B06-A0001Model ACCENT M320Ref B06-A0002Ref B05-A0002Model ACCENT MC240Ref B05-A0001
Identity
- Device Name
- CHEMISTRY ANALYZER EUDAMED
- Model / Reference
- ACCENT M320 EUDAMEDB06-A0001 EUDAMEDB06-A0002 EUDAMEDACCENT MC240 EUDAMEDB05-A0002 EUDAMEDB05-A0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514600243 EUDAMED05907514601684 EUDAMED05907514601677 EUDAMED05907514600236 EUDAMED
- Basic UDI-DI
- 59075146AccentM320SW EUDAMED59075146AccentMC240XS EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMEDW0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800) EUDAMEDW0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
Chemistry Analyzer by PZ CORMAY Spółka Akcyjna — 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 | 59075146AccentM320SW | Class A | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (4)
- EUDAMED b95e85f6-f2a8-4090-9d4c-84fac15e9dcd 61 fields · synced Jul 29, 2026
- EUDAMED 016b98a9-6168-47ff-a1f8-862ca7910ab7 61 fields · synced May 17, 2026
- EUDAMED 3972b564-5d37-403e-9050-ef8e12242ced 61 fields · synced May 18, 2026
- EUDAMED c0733719-1c64-4c94-ad11-a5ce78f1bbce 61 fields · synced May 19, 2026