Identity
- Trade Name
- Lp-PLA2 (CLIA) EUDAMED
- Device Name
- Lp-PLA2 (CLIA) EUDAMED
- Model / Reference
- MCL03801E EUDAMEDMCL03802E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604441 EUDAMED06926802604458 EUDAMED
- Basic UDI-DI
- B-06926802604441 EUDAMEDB-06926802604458 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Lp-PLA2 (CLIA) by Medcaptain 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-06926802604441 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED db02b8ac-c884-49a8-a743-4bfa954951ab 61 fields · synced Jul 31, 2026
- EUDAMED 27abe6f7-bfb5-4d62-9c8c-dc9c7f6a84a9 61 fields · synced May 17, 2026