Identity
- Trade Name
- Micro Staining Kit Auto Gram (2500 mL) EUDAMED
- Device Name
- GRAM and GRAM PVP STAIN EUDAMED
- Model / Reference
- 998609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18430155010316 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
Micro Staining Kit Auto Gram (2500 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 (1)
- EUDAMED 3eddc51d-39a6-424d-8e93-ff5b836188ca 61 fields · synced Oct 6, 2026