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TB Auramine Rhodamine (Truant) kit (3x250mL)
EUDAMEDClass A (EU MDR)
Ref 999320
Identity
- Trade Name
- TB Auramine Rhodamine (Truant) kit (3x250mL) EUDAMED
- Device Name
- AURAMINA RHODAMINE TRUANT STAIN EUDAMED
- Model / Reference
- 999320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18430155005374 EUDAMED
- Basic UDI-DI
- 8430155AURAMINARODAMINADF 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 Rhodamine (Truant) 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 | 8430155AURAMINARODAMINADF | Class A | Active |
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Manufacturer
- Manufacturer
- Quimica Clinica Aplicada S.a.
- EUDAMED SRN
- ES-MF-000001512
Sources (1)
- EUDAMED 7803f64c-0cc3-43c3-8221-9631fb4f596d 61 fields · synced Jul 9, 2026