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Polychromic solution EA-50
EUDAMEDClass A (EU MDR)
Ref HS009Model HS006 - HS007 - HS009
Identity
- Trade Name
- Polychromic solution EA-50 EUDAMED
- Device Name
- Papanicolaou's Stains EUDAMED
- Model / Reference
- HS006 - HS007 - HS009 EUDAMEDHS009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100202 EUDAMED
- Basic UDI-DI
- 54040351HS0066B EUDAMED
- Direct Marketing DI
- 05404035100202 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
New Device
No
EUDAMED
Polychromic solution EA-50 by Cypress Diagnostics — 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 | 54040351HS0066B | Class A | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED 301e5102-578c-4a38-aa9e-728cc3457e1e 61 fields · synced Jul 19, 2026
- EUDAMED 2a6a31bd-fbe4-43e5-ae4e-b94893765d74 61 fields · synced Jul 19, 2026