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AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref BT0505603Ref BT0505602Ref BT0505604Ref BT0505601Ref BT0505605
Identity
- Trade Name
- AFP Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- AFP Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0505603 EUDAMEDBT0505602 EUDAMEDBT0505604 EUDAMEDBT0505601 EUDAMEDBT0505605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260207145 EUDAMED06933260207138 EUDAMED06933260207152 EUDAMED06933260207121 EUDAMED06933260207169 EUDAMED
- Basic UDI-DI
- B-06933260207145 EUDAMEDB-06933260207138 EUDAMEDB-06933260207152 EUDAMEDB-06933260207121 EUDAMEDB-06933260207169 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN 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
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
AFP 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-06933260207145 | 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 106a9e4d-731c-495e-b062-b042a0ea71a4 61 fields · synced Oct 6, 2026
- EUDAMED 70df8bc8-82f9-42f5-a514-52d96544242a 61 fields · synced May 17, 2026
- EUDAMED ef115d90-de35-4479-8053-cad7ed07acc3 61 fields · synced May 17, 2026
- EUDAMED 9f6fba7d-a731-4190-9c51-1cb4ffd4695a 61 fields · synced May 18, 2026
- EUDAMED d476cd40-e152-41e4-a224-ab61d593f05e 61 fields · synced May 19, 2026
- EUDAMED e15702d5-32f6-4d92-93f4-50bfafff85e4 61 fields · synced Jun 18, 2026
- EUDAMED d8beec90-981b-467d-b525-78da430c490f 61 fields · synced Jul 12, 2026
- EUDAMED bc1d1df1-7269-44c2-b85e-4bf3339b02ab 61 fields · synced Jul 22, 2026
- EUDAMED b72f6ea2-60b3-4643-be40-6e794854ee86 61 fields · synced Jul 23, 2026
- EUDAMED 86f24aab-4e39-4c3c-a25a-ca73ef4b2a13 61 fields · synced Jul 28, 2026