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Lipoprotein Phospholipase A2 Determination Kit (Fluorescence Immunochromatograp…
EUDAMEDClass B (EU MDR)
Ref P11511Model 25 tests/box
Identity
- Trade Name
- Lipoprotein Phospholipase A2 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Lipoprotein Phospholipase A2 Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581108 EUDAMED
- Basic UDI-DI
- 697518250P115086K EUDAMED
- Direct Marketing DI
- 06942293581108 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Lipoprotein Phospholipase A2 Determination Kit (Fluorescence Immunochromatograp… by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in…
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 | 697518250P115086K | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d8641caf-9cda-4776-af9a-d96806794841 61 fields · synced Oct 6, 2026