Identity
- Trade Name
- Gram Fuchsin (1000 mL) EUDAMED
- Device Name
- GRAM and GRAM PVP STAIN EUDAMED
- Model / Reference
- 997217 EUDAMED995617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430155005117 EUDAMED08430155008484 EUDAMED
- Basic UDI-DI
- 8430155GRAMPVPWF 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
Gram Fuchsin (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 | 8430155GRAMPVPWF | Class A | Active |
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Manufacturer
- Manufacturer
- Quimica Clinica Aplicada S.a.
- EUDAMED SRN
- ES-MF-000001512
Sources (2)
- EUDAMED 01cb63f5-87f2-4b38-bb81-6d803aeb821d 61 fields · synced Oct 6, 2026
- EUDAMED 39d9c421-ebb6-4845-9fcf-ca2f42602edb 61 fields · synced May 18, 2026