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Lp-PLA2 STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320511503Model 100TRef 0320511504Model 2×100T
Identity
- Trade Name
- Lp-PLA2 STAT (eCLIA) EUDAMED
- Device Name
- Lp-PLA2 STAT (eCLIA) EUDAMED
- Model / Reference
- 100T EUDAMED0320511503 EUDAMED2×100T EUDAMED0320511504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139078266 EUDAMED06978139078273 EUDAMED
- Basic UDI-DI
- B-06978139078266 EUDAMEDB-06978139078273 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Lp-PLA2 STAT (eCLIA) by Shenzhen Lifotronic 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-06978139078266 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1b6d525e-b764-4348-9b12-3a622dae10d6 61 fields · synced Jul 22, 2026
- EUDAMED 5c7a8165-95d8-429d-ae30-35bd219eb4e1 61 fields · synced May 18, 2026