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hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0501202
Identity
- Trade Name
- hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMED
- Device Name
- hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0501202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260204656 EUDAMED
- Basic UDI-DI
- B-06933260204656 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
hs-CRP 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-06933260204656 | 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 (3)
- EUDAMED 80dca638-cdfb-4279-b8a9-1e449854d1ef 61 fields · synced Oct 7, 2026
- EUDAMED 3e06acf6-e0f5-441d-befd-7dc662192c3d 61 fields · synced Jul 28, 2026
- EUDAMED 1c153f00-2f79-4458-84a5-8c6043ab7266 61 fields · synced Oct 7, 2026