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SYSTEM SOLUTION for ELITech Clinical Systems Analyzers
EUDAMEDFDA UDIClass A (EU MDR)
Ref SLSY-5900
Identity
- Trade Name
- SYSTEM SOLUTION for ELITech Clinical Systems Analyzers EUDAMEDSYSTEM SOLUTION For ELITech Clinical Systems Analysers FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- SYSTEM SOLUTION EUDAMED
- Model / Reference
- SLSY-5900 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540217425 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540SLSY06XQ EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- 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
No
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
No
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
SYSTEM SOLUTION for ELITech Clinical Systems Analyzers by Vitalscientific — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 3661540SLSY06XQ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED eb005d5e-b070-4c4f-9462-77f22ce89f47 61 fields · synced Jun 18, 2026
- FDA UDI 81c73573-561e-4880-94a3-45466940f6a1 32 fields · synced May 30, 2026