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Apolipoprotein C2 Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref APOC26011Y, APOC26012Y, APOC26013Y, APOC26014Y, APOC26015Y, APOC26011N, APOC26012N, APOC26013N, APOC26014N, APOC26015N
Identity
- Trade Name
- Apolipoprotein C2 Reagent Kit EUDAMED
- Device Name
- Apolipoprotein C2 Reagent Kit EUDAMED
- Model / Reference
- APOC26011Y, APOC26012Y, APOC26013Y, APOC26014Y, APOC26015Y, APOC26011N, APOC26012N, APOC26013N, APOC26014N, APOC26015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-APOC2601FA EUDAMED
- Basic UDI-DI
- B-APOC2601FA EUDAMED
- EMDN Code
- W0102010499 LIPOPROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
Apolipoprotein C2 Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-APOC2601FA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 37dd89cc-2edf-4550-a178-557a69c3ab43-1 61 fields · synced Jul 17, 2026
- EUDAMED 37dd89cc-2edf-4550-a178-557a69c3ab43-2 61 fields · synced Jul 17, 2026