Identity
- Trade Name
- TB Decolorizer (1000 mL) EUDAMED
- Device Name
- ZIEHL NEELSEN STAIN EUDAMED
- Model / Reference
- 997115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430155005100 EUDAMED
- Basic UDI-DI
- 8430155ZIEHLNEELSENV6 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 Decolorizer (1000 mL) 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 | 8430155ZIEHLNEELSENV6 | Class A | Active |
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Manufacturer
- Manufacturer
- Quimica Clinica Aplicada S.a.
- EUDAMED SRN
- ES-MF-000001512
Sources (1)
- EUDAMED 0ce374fd-70af-4363-a476-94b7a3f9778f 61 fields · synced Oct 6, 2026