Identity
- Trade Name
- Alinity c Lp(a) Reagent Kit EUDAMED
- Device Name
- Alinity c Lp(a) Reagent Kit EUDAMED
- Model / Reference
- 01R1420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380740153830 EUDAMED
- Basic UDI-DI
- 8436003070467XU EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Category: Apolipoprotein B (Apo B) IVD, reagent
Alinity c Lp(a) Reagent Kit by Biokit, S.a. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Apolipoprotein B (Apo B) IVD, reagent.
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- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
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 | 8436003070467XU | Class B | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 12843659-f909-42c0-bf75-19c9a3df4d4d 61 fields · synced Jul 25, 2026