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FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0502004Ref BT0502001Ref BT2215Ref BT0502002Ref BT0502003Ref BT0502005
Identity
- Trade Name
- FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMEDFT4 Rapid Quantitative Test EUDAMED
- Device Name
- FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMEDFT4 Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT0502004 EUDAMEDBT0502001 EUDAMEDBT2215 EUDAMEDBT0502002 EUDAMEDBT0502003 EUDAMEDBT0502005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260205073 EUDAMED06933260205042 EUDAMED06933260208081 EUDAMED06933260205059 EUDAMED06933260205066 EUDAMED06933260205080 EUDAMED
- Basic UDI-DI
- B-06933260205073 EUDAMEDB-06933260205042 EUDAMEDB-06933260208081 EUDAMEDB-06933260205059 EUDAMEDB-06933260205066 EUDAMEDB-06933260205080 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMEDW01020402 FREE THYROXINE 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
FT4 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-06933260205073 | 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 (12)
- EUDAMED 1efe7fd9-68c8-45e3-9816-6fe3110eeb5b 61 fields · synced Oct 5, 2026
- EUDAMED 73ddfb17-6ce3-4994-88c6-69e01a9bfb11 61 fields · synced May 17, 2026
- EUDAMED 7b6da861-458b-4832-b97f-3254096ff43a 61 fields · synced May 18, 2026
- EUDAMED b400366e-1e86-449c-b666-4e12058238be 61 fields · synced May 18, 2026
- EUDAMED e7512fc9-347f-4344-acf7-1dd69831e320 61 fields · synced May 18, 2026
- EUDAMED 21c31db2-14f1-4d77-a8d9-7ce58b0b2489 61 fields · synced May 19, 2026
- EUDAMED dafb593d-c70f-4b94-8f8e-073038ba9126 61 fields · synced Jul 9, 2026
- EUDAMED 7c6601bf-a177-4dc1-baa4-ae8195540022 61 fields · synced Jul 15, 2026
- EUDAMED cf5f9e68-18c0-45b9-882e-0e32f229de2b 61 fields · synced Jul 16, 2026
- EUDAMED e85f7e66-5626-46c6-b5a8-cdb61ecdbebc 61 fields · synced Jul 21, 2026
- EUDAMED ac9ebcfc-3057-4ea7-9418-010e6be3863c 61 fields · synced Jul 28, 2026
- EUDAMED b858f59e-9ffa-40e1-9a25-66cefce3eada 61 fields · synced Oct 5, 2026