Identity
- Trade Name
- AMIDOBLACK STAINING SOLUTION EUDAMEDAMIDO BLACK STAINING SOLUTION FDA UDI
- Generic Name
- Citrate staining/testing reagent IVD FDA UDI
- Device Name
- AMIDOBLACK STAINING SOLUTION EUDAMED
- Model / Reference
- 4554 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 4554 FDA UDI
- Primary DI / UDI-DI
- 03607360045541 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607364554BUEJ EUDAMED
- FDA Product Code
- CEF FDA UDI
- EMDN Code
- W01010499 MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER EUDAMED
- GMDN Term
- Citrate staining/testing reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1630 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Amidoblack Staining Solution by Sebia — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3607364554BUEJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED 732bf843-7867-4116-b2ae-d230baa9505a 61 fields · synced Jul 9, 2026
- FDA UDI a6ee2686-db20-4be5-bb0f-a28397d56dbd 34 fields · synced May 30, 2026