← Back to catalogue
Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0500805Ref BT2223Ref BT0500802Ref BT0500804
Identity
- Trade Name
- Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMEDLp-PLA2 Rapid Quantitative Test EUDAMED
- Device Name
- Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMEDLp-PLA2 Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT0500805 EUDAMEDBT2223 EUDAMEDBT0500802 EUDAMEDBT0500804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260204489 EUDAMED06933260208005 EUDAMED06933260204458 EUDAMED06933260204472 EUDAMED
- Basic UDI-DI
- B-06933260204489 EUDAMEDB-06933260208005 EUDAMEDB-06933260204458 EUDAMEDB-06933260204472 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06933260204489 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (7)
- EUDAMED e25f0298-a9e8-4056-be92-074cb2a705af 61 fields · synced Oct 6, 2026
- EUDAMED bd4a793a-dd61-4767-8354-11cb4bd0ae4a 61 fields · synced May 17, 2026
- EUDAMED 0a429298-29cb-4f0e-85bc-9d4d75def024 61 fields · synced May 17, 2026
- EUDAMED 28579c65-96f8-42c6-aaed-b0b18ce5c635 61 fields · synced May 18, 2026
- EUDAMED f5d07f66-eafd-40a2-8afd-4139b77e3cf3 61 fields · synced Jun 20, 2026
- EUDAMED 58e2cf5b-f913-477c-9756-693f680cd286 61 fields · synced Jul 11, 2026
- EUDAMED a721c1b7-d4ed-4fcb-93dd-5cc7f3378b78 61 fields · synced Jul 21, 2026