Identity
- Trade Name
- Gram Decolorizer (6 x 250 mL) EUDAMED
- Device Name
- GRAM and GRAM PVP STAIN EUDAMED
- Model / Reference
- 997670 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18430155005145 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
Unlock the power of ultrasound technology with Gram Decolorizer, a reliable and versatile device designed for endoscopic procedures. This Class A medical device features advanced self-testing capabilities, making it an ideal solution for clinicians looking to improve their accuracy and efficiency. With its comprehensive suite of features, Gram Decolorizer is perfect for any medical practice seeking to enhance patient care.
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 cf0dacb2-f505-4f55-ac3d-373ea55a39b0 61 fields · synced Oct 6, 2026