Identity
- Trade Name
- HbA1c Lyse 1x125 mL EUDAMED
- Device Name
- HbA1c Lyse 1x125 mL EUDAMED
- Model / Reference
- 3156005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8435287373004 EUDAMED
- Basic UDI-DI
- 843528737300H4 EUDAMED
- Direct Marketing DI
- 8435287373004 EUDAMED
- EMDN Code
- W0101070304 COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES) 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
HbA1c Lyse 1x125 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 | 843528737300H4 | Class A | Active |
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Manufacturer
- Manufacturer
- Linear Chemicals S.L.U
- EUDAMED SRN
- ES-MF-000003284
Sources (1)
- EUDAMED 8c16eaa5-4e96-4e27-a953-46b2a33af2e7 61 fields · synced Jun 18, 2026