Identity
- Trade Name
- Systemic Solution (400x) 10 x 50 mL EUDAMED
- Device Name
- Systemic Solution (400x) 10 x 50 mL EUDAMED
- Model / Reference
- KR18300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8435287370201 EUDAMED
- Basic UDI-DI
- 843528737020GT EUDAMED
- Direct Marketing DI
- 8435287370201 EUDAMED
- EMDN Code
- W0101070302 ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS 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
Systemic Solution (400x) 10 x 50 mL by Linear Chemicals S.L.U — 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 | 843528737020GT | Class A | Active |
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Manufacturer
- Manufacturer
- Linear Chemicals S.L.U
- EUDAMED SRN
- ES-MF-000003284
Sources (1)
- EUDAMED 3aa684a2-b995-44d6-82ce-41967e6c3c3a 61 fields · synced Jul 21, 2026