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hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0500505Ref BT0500504Ref BT0500503Ref BT0500501
Identity
- Trade Name
- hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0500505 EUDAMEDBT0500504 EUDAMEDBT0500503 EUDAMEDBT0500501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260204335 EUDAMED06933260204328 EUDAMED06933260204311 EUDAMED06933260204298 EUDAMED
- Basic UDI-DI
- B-06933260204335 EUDAMEDB-06933260204328 EUDAMEDB-06933260204311 EUDAMEDB-06933260204298 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-cTnT 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-06933260204335 | 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 (8)
- EUDAMED 4dc931ee-3d8a-46cf-a126-b2eba0340981 61 fields · synced Oct 6, 2026
- EUDAMED fa1627f5-01d5-4a83-9c04-6041af64a2c8 61 fields · synced May 18, 2026
- EUDAMED 8b0452e0-c72d-48f4-b86a-e644c7d88dee 61 fields · synced May 18, 2026
- EUDAMED 818e8327-ea9b-4783-b3b8-d2a602a88606 61 fields · synced May 18, 2026
- EUDAMED 60ea636a-d70d-4fec-9820-0a2d4e03cce5 61 fields · synced Jun 19, 2026
- EUDAMED 0dc8f56f-6230-4d58-bd27-aadc12e2e075 61 fields · synced Jul 9, 2026
- EUDAMED de1a818c-a616-4c7b-b88c-aaa61884b45b 61 fields · synced Jul 16, 2026
- EUDAMED 83a869cc-ebb3-4dc6-a75c-71480a011237 61 fields · synced Jul 20, 2026