Identity
- Trade Name
- TB Auramine (Morse) kit (3x250mL) EUDAMED
- Device Name
- AURAMINA MORSE STAIN EUDAMED
- Model / Reference
- 993810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18430155004803 EUDAMED
- Basic UDI-DI
- 8430155AURAMINA35 EUDAMED
- EMDN Code
- W0104010804 STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
TB Auramine (Morse) kit (3x250mL) by Quimica Clinica Aplicada S.a. — 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 | 8430155AURAMINA35 | Class A | Active |
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Manufacturer
- Manufacturer
- Quimica Clinica Aplicada S.a.
- EUDAMED SRN
- ES-MF-000001512
Sources (1)
- EUDAMED e03d2d76-562c-4609-996b-5f92e982a50e 61 fields · synced Oct 6, 2026