Identity
- Trade Name
- BIOTIME EUDAMED
- Device Name
- 25(OH) D Rapid Quantitative Test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- BT0504505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260206568 EUDAMED
- Basic UDI-DI
- B-06933260206568 EUDAMED
- EMDN Code
- W0102070206 VITAMIN D (CHOLECALCIFEROL) 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
Biotime by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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-06933260206568 | 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 51251fe6-6328-4ac6-b1eb-919ad147c0a0 61 fields · synced Oct 6, 2026
- EUDAMED 06767c6b-fe91-4abf-984a-eace4cb2f391 61 fields · synced Jul 10, 2026