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Accent-200 Amylase
EUDAMEDClass IVD General (EU MDR)
Ref 7-255Model ACCENT-200 AMYLASE
Identity
- Trade Name
- ACCENT-200 AMYLASE EUDAMED
- Device Name
- AMYLASE EUDAMED
- Model / Reference
- ACCENT-200 AMYLASE EUDAMED7-255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514672554 EUDAMED
- Basic UDI-DI
- B-05907514672554 EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Accent-200 Amylase by PZ CORMAY Spółka Akcyjna — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05907514672554 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (1)
- EUDAMED e13a730d-8787-44a8-a8fa-89f8648207c5 61 fields · synced Jun 18, 2026