← Back to catalogue
Sudan Black B Staining System
EUDAMEDClass A (EU MDR)
Ref 3802-75MLModel 380Ref 380B-1KT
Identity
- Trade Name
- SUDAN BLACK B STAINING SYSTEM EUDAMED
- Device Name
- SUDAN BLACK B STAINING SYSTEM EUDAMED
- Model / Reference
- 380 EUDAMED3802-75ML EUDAMED380B-1KT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061831960358 EUDAMED04061831960860 EUDAMED
- Basic UDI-DI
- 040618380JV 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
Sudan Black B Staining System by Sigma-Aldrich Corporation — 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 | 040618380JV | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 845f90ac-2754-4609-981c-319d1abcdb9d 61 fields · synced Oct 6, 2026
- EUDAMED a7ac27a6-633e-4d5a-9862-e925d3c32dc1 61 fields · synced May 18, 2026
- EUDAMED 30360dc0-5213-4f0b-a11d-754c5ffcced0 61 fields · synced Jul 10, 2026