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ST2 Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0501002
Identity
- Trade Name
- ST2 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- ST2 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0501002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260204557 EUDAMED
- Basic UDI-DI
- B-06933260204557 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
ST2 Rapid Quantitative Test (Chemiluminescence Immunoassay) by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
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 | B-06933260204557 | 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 (2)
- EUDAMED 4e65053c-602d-43ad-a4ed-0a66b0abace1 61 fields · synced Oct 6, 2026
- EUDAMED f42e31e0-fecf-494c-8ae0-96bdd56816b6 61 fields · synced Jul 16, 2026