Identity
- Trade Name
- Crystal violet EUDAMED
- Device Name
- Rapid Gram Stain EUDAMED
- Model / Reference
- 4×250ml EUDAMED6×500ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952383300632 EUDAMED06952383300953 EUDAMED
- Basic UDI-DI
- 695238330002GD EUDAMED
- Direct Marketing DI
- 06952383300632 EUDAMED06952383300953 EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Crystal violet by Baso Diagnostics Inc. Zhuhai — 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 | 695238330002GD | Class A | Active |
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Manufacturer
- Manufacturer
- Baso Diagnostics Inc. Zhuhai
- EUDAMED SRN
- CN-MF-000050424
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (4)
- EUDAMED a12c7735-73a4-4904-b985-703cbba86fe7 61 fields · synced Sep 18, 2026
- EUDAMED 447dee6a-47a7-406e-97cf-8fd7cd5179ba 61 fields · synced May 18, 2026
- EUDAMED f0df4dde-490f-466a-a12d-7861c761d84a 61 fields · synced Aug 4, 2026
- EUDAMED d6e4cf22-e5a8-4eb5-9124-6642f2d49d13 61 fields · synced Sep 18, 2026