Identity
- Trade Name
- Ziehl-Neelsen EUDAMED
- Device Name
- Ziehl-Neelsen - Carbol Fuchsin - Kühne's Methylene Blue EUDAMED
- Model / Reference
- HS002 - HS015 - HS016 EUDAMEDHS002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035100233 EUDAMED
- Basic UDI-DI
- 54040351HS00263 EUDAMED
- Direct Marketing DI
- 05404035100233 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
Ziehl-Neelsen 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 | 54040351HS00263 | Class A | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED 0bdb7f01-9f42-4e5a-9b95-0add0e9d0e69 61 fields · synced Jul 14, 2026
- EUDAMED 2843d3d2-b998-4f11-b7f8-356de60d56af 61 fields · synced Jul 14, 2026