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PCT Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0501402Ref BT0501403Ref BT0501401Ref BT0501405Ref BT2301
Identity
- Trade Name
- PCT Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMEDPCT Rapid Quantitative Test EUDAMED
- Device Name
- PCT Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMEDPCT Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT0501402 EUDAMEDBT0501403 EUDAMEDBT0501401 EUDAMEDBT0501405 EUDAMEDBT2301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260204755 EUDAMED06933260204762 EUDAMED06933260204748 EUDAMED06933260204786 EUDAMED06933260208470 EUDAMED
- Basic UDI-DI
- B-06933260204755 EUDAMEDB-06933260204762 EUDAMEDB-06933260204748 EUDAMEDB-06933260204786 EUDAMEDB-06933260208470 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMEDW0102069013 PROCALCITONIN 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
PCT 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-06933260204755 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (10)
- EUDAMED 0f17b69a-8b4f-4d9e-8c69-7b630856a862 61 fields · synced Oct 6, 2026
- EUDAMED bea2c515-3ad2-4a3a-bc93-9012904de390 61 fields · synced May 18, 2026
- EUDAMED 9b8ba807-a643-463d-8e81-e33f88c63fed 61 fields · synced May 18, 2026
- EUDAMED 89fef849-0cd5-487c-b324-cadc1b9a6885 61 fields · synced May 18, 2026
- EUDAMED 6f110af3-510f-4ff4-9700-d7a602d5ddb0 61 fields · synced May 19, 2026
- EUDAMED f5c4f2c4-5e6a-4d43-932e-e890c62e4df0 61 fields · synced Jun 18, 2026
- EUDAMED a532cd69-00a4-4cc1-a4be-2cf0b9a2b9c5 61 fields · synced Jul 14, 2026
- EUDAMED 25ac1082-f1e1-4570-aa9d-147ad0c0be8b 61 fields · synced Jul 25, 2026
- EUDAMED 4ea75430-276a-473d-8987-cb99c7de62b7 61 fields · synced Jul 29, 2026
- EUDAMED 6e55cef1-db15-4e4e-9afe-e50198d18e74 61 fields · synced Jul 29, 2026