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Carbol Gentian Violet
EUDAMEDClass A (EU MDR)
Ref HS021Model HS001 - HS014 - HS021 - HS022
Identity
- Trade Name
- Carbol Gentian Violet EUDAMED
- Device Name
- Gram PVP - Safranin - Carbol Gentian Violet - Lugol Stabilized with PVP EUDAMED
- Model / Reference
- HS001 - HS014 - HS021 - HS022 EUDAMEDHS021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100172 EUDAMED
- Basic UDI-DI
- 54040351HS0015Z EUDAMED
- Direct Marketing DI
- 05404035100172 EUDAMED
- EMDN Code
- W0104010804 STAINS 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
Carbol Gentian Violet 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 | 54040351HS0015Z | Class A | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED 8c003ebe-6f2a-402d-bbd8-9165265f3cb3 61 fields · synced Jun 18, 2026